{ "id": "prevacid", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-22", "status": "published_traceable_archive" }, "names": { "brand": "Prevacid", "generic": "兰索拉唑", "aliases": [ "PREVACID", "PREVACID SoluTab", "lansoprazole", "兰索拉唑" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "消化系统", "sourceArchiveMarket": "美国 DailyMed 当前公开标签（2025-03 修订）；此页仅展示该标签明确对应的 30 mg 胶囊及 15 mg、30 mg SoluTab 包装面板，不据此建立目标市场可得性结论。", "dosageFormClass": "30 mg 延迟释放胶囊；15 mg、30 mg 延迟释放口崩片（DailyMed 2025-03 公开标签所列）", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1995（DailyMed 2025-03 美国公开标签所列初始批准）", "archiveSponsorText": "Takeda / DailyMed 公开监管标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "PREVACID 15 mg delayed-release capsules", "PREVACID 15 mg capsules" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-prevacid-lansoprazole-delayed-release-capsule-30mg-100-bottle-ndc-64764-046-13", "marketCode": "US", "labelVersion": { "zh": "2025-03 修订", "en": "revised Mar 2025" }, "dosageForm": { "zh": "兰索拉唑延迟释放胶囊", "en": "lansoprazole delayed-release capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 64764-046-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "30 mg／粒；100 粒瓶装", "en": "30 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=prevacid-04.jpg&setid=71ba78cb-7e46-43eb-9425-fa130f537f84&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "兰索拉唑", "en": "lansoprazole" }, "value": 30, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人服用数量、调整或换算指令", "en": "labelled amount per capsule; not an individual amount, adjustment or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-22", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "不透明粉色与黑色", "en": "opaque pink and black" }, "shape": { "zh": "延迟释放胶囊", "en": "delayed-release capsule" }, "imprint": "TAP / PREVACID 30", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fe786172b22ae19e", "label": "DailyMed（NLM）：PREVACID / PREVACID SoluTab 当前美国公开标签（Takeda；2025-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=71ba78cb-7e46-43eb-9425-fa130f537f84", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-prevacid-solutab-lansoprazole-delayed-release-odt-15mg-100-carton-ndc-64764-543-11", "marketCode": "US", "labelVersion": { "zh": "2025-03 修订", "en": "revised Mar 2025" }, "dosageForm": { "zh": "PREVACID SoluTab 兰索拉唑延迟释放口崩片", "en": "PREVACID SoluTab lansoprazole delayed-release orally disintegrating tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 64764-543-11", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "15 mg／片；100 片单剂量包装纸盒（10 包 × 每包 10 片）", "en": "15 mg per tablet; 100-tablet unit-dose carton (10 packs of 10 tablets)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=prevacid-05.jpg&setid=71ba78cb-7e46-43eb-9425-fa130f537f84&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "兰索拉唑", "en": "lansoprazole" }, "value": 15, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用数量、调整或换算指令", "en": "labelled amount per tablet; not an individual amount, adjustment or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "unit_dose_carton", "typeLabel": { "zh": "单剂量包装纸盒", "en": "unit-dose package carton" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/盒", "en": "tablets per carton" }, "unitsPerContainer": { "count": 10, "unit": { "zh": "片/单剂量包装", "en": "tablets per unit-dose pack" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-22", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/盒", "en": "tablets per carton" } }, "physicalClues": { "color": { "zh": "白色至淡黄色白色，带橙色至深棕色斑点", "en": "white to yellowish white with orange to dark-brown speckles" }, "shape": { "zh": "圆形无包衣口崩片", "en": "round uncoated orally disintegrating tablet" }, "imprint": "15", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fe786172b22ae19e", "label": "DailyMed（NLM）：PREVACID / PREVACID SoluTab 当前美国公开标签（Takeda；2025-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=71ba78cb-7e46-43eb-9425-fa130f537f84", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-prevacid-solutab-lansoprazole-delayed-release-odt-30mg-100-carton-ndc-64764-544-11", "marketCode": "US", "labelVersion": { "zh": "2025-03 修订", "en": "revised Mar 2025" }, "dosageForm": { "zh": "PREVACID SoluTab 兰索拉唑延迟释放口崩片", "en": "PREVACID SoluTab lansoprazole delayed-release orally disintegrating tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 64764-544-11", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "30 mg／片；100 片单剂量包装纸盒（10 包 × 每包 10 片）", "en": "30 mg per tablet; 100-tablet unit-dose carton (10 packs of 10 tablets)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=prevacid-06.jpg&setid=71ba78cb-7e46-43eb-9425-fa130f537f84&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "兰索拉唑", "en": "lansoprazole" }, "value": 30, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用数量、调整或换算指令", "en": "labelled amount per tablet; not an individual amount, adjustment or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "unit_dose_carton", "typeLabel": { "zh": "单剂量包装纸盒", "en": "unit-dose package carton" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/盒", "en": "tablets per carton" }, "unitsPerContainer": { "count": 10, "unit": { "zh": "片/单剂量包装", "en": "tablets per unit-dose pack" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-22", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/盒", "en": "tablets per carton" } }, "physicalClues": { "color": { "zh": "白色至淡黄色白色，带橙色至深棕色斑点", "en": "white to yellowish white with orange to dark-brown speckles" }, "shape": { "zh": "圆形无包衣口崩片", "en": "round uncoated orally disintegrating tablet" }, "imprint": "30", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fe786172b22ae19e", "label": "DailyMed（NLM）：PREVACID / PREVACID SoluTab 当前美国公开标签（Takeda；2025-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=71ba78cb-7e46-43eb-9425-fa130f537f84", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=prevacid-04.jpg&setid=71ba78cb-7e46-43eb-9425-fa130f537f84&type=img", "alt": "PREVACID 30 mg 兰索拉唑延迟释放胶囊在美国 DailyMed 公开标签中的 Takeda 100 粒瓶装标签图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Takeda，2025-07 更新；处方信息 2025-03 修订）", "presentation": "PREVACID 30 mg、100 粒延迟释放胶囊瓶装标签图（DailyMed 公开标签所列；Takeda 标签图）。", "notice": "此为美国 DailyMed 公开标签中明确对应 PREVACID 30 mg、100 粒延迟释放胶囊的 Takeda 标签图，只帮助核对品牌、通用名、标示强度、延迟释放胶囊、包装数量和来源；不用于鉴定真伪，也不证明 PREVACID SoluTab、15 mg 口崩片、其他包装、其他市场标签、当前包装、原研身份、目标市场批准或可售资格。", "source": { "id": "src_fe786172b22ae19e", "label": "DailyMed（NLM）：PREVACID / PREVACID SoluTab 当前美国公开标签（Takeda，2025-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=71ba78cb-7e46-43eb-9425-fa130f537f84", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "PREVACID 说明书放大阅读：延迟释放胶囊与口崩片的产品身份要分开看", "en": "PREVACID label reading: delayed-release capsules and orally disintegrating tablets need separate product identity" }, "summary": { "zh": "本模块以 Takeda 的 DailyMed 美国公开标签为阅读入口（页面 2025-07 更新；处方信息 2025-03 修订），帮助分开核对 PREVACID 30 mg 延迟释放胶囊，以及 PREVACID SoluTab 15 mg/30 mg 延迟释放口崩片；它不提供个人服用数量、疗程、停药或换药方案。", "en": "This module uses Takeda's U.S. DailyMed public label as a reading entry point (page updated Jul 2025; prescribing information revised Mar 2025). It separates PREVACID 30 mg delayed-release capsules from PREVACID SoluTab 15 mg/30 mg delayed-release orally disintegrating tablets; it does not provide an individual's amount, duration, stopping or switching plan." }, "checks": [ { "zh": "先把商品名、兰索拉唑、剂型、标示强度和目标市场一起核对。30 mg PREVACID 胶囊与 15 mg/30 mg PREVACID SoluTab 是同一公开标签中分别列出的不同制剂；相同通用名或相近 mg 不能自动等同、互换或用来推算“该吃几颗”。", "en": "Check brand, lansoprazole, dosage form, labelled strength and target market together. The 30 mg PREVACID capsule and 15 mg/30 mg PREVACID SoluTab are separately listed dosage forms in the same public label; a shared generic name or nearby mg number does not make them automatically equivalent, interchangeable or a way to calculate “how many to take.”" }, { "zh": "这份准确美国标签写明：胶囊应整粒吞服、不要咀嚼；但对吞咽困难者，它另列了“打开胶囊后按标签指定的软食或液体给药”的具体方式。这个产品特定例外不等于任何延迟释放胶囊、任何包装或任何市场都可以打开、掰半、研碎或混入食物。", "en": "This exact U.S. label says to swallow the capsule whole and not chew it; for people who have difficulty swallowing, it separately lists specific labelled soft-food or liquid administration after opening the capsule. That product-specific exception does not mean every delayed-release capsule, pack or market may be opened, split, crushed or mixed with food." }, { "zh": "对 PREVACID SoluTab，标签写明可在舌上崩解后吞下微粒，但不要咀嚼微粒；它也列有针对特定人群和器械的给药步骤。不要把“口崩”理解成可咀嚼、研碎、分半，或套用到普通片剂、其他口崩片和其他兰索拉唑产品。", "en": "For PREVACID SoluTab, the label says the tablet may disintegrate on the tongue and the microgranules are swallowed without chewing; it also lists administration steps for specific people and devices. Do not read “orally disintegrating” as permission to chew, crush or split it, or as a rule for ordinary tablets, other orally disintegrating tablets or other lansoprazole products." }, { "zh": "不要因都被称为抑酸药，就把 PREVACID 与 NEXIUM、PRILOSEC、非处方胃药或其他处方药自行并用、轮换或换算。用途相似只能提示需要核对，不能构成个人用药结论。", "en": "Do not self-combine, alternate or convert PREVACID with NEXIUM, PRILOSEC, OTC stomach products or another prescription merely because all are called acid-suppressing medicines. A similar purpose only signals a need to review; it cannot establish an individual medicine conclusion." }, { "zh": "出现严重或持续不适、对吞咽或剂型操作不确定，或正在使用多种药物时，请带完整药单和实际包装联系专业人员；本页不判断继续、暂停或如何调整。", "en": "With severe or persistent symptoms, uncertainty about swallowing or formulation handling, or multiple medicines in use, bring the complete list and actual package to a professional; this page does not decide continuation, pause or adjustment." } ], "source": { "id": "src_fe786172b22ae19e", "label": "DailyMed（NLM）：PREVACID / PREVACID SoluTab 当前美国公开标签（Takeda；页面 2025-07 更新，处方信息 2025-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=71ba78cb-7e46-43eb-9425-fa130f537f84", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "兰索拉唑怎样起作用：它抑制胃壁细胞的质子泵", "en": "How lansoprazole works: it inhibits the gastric parietal-cell proton pump" }, "summary": { "zh": "DailyMed 的 Takeda 标签将兰索拉唑描述为质子泵抑制剂，说明其在胃壁细胞酸性环境中转化为活性形式并抑制 H+/K+-ATPase。它仅用于解释药理路径，不给出个人使用时机、强度、疗程或与其他抑酸药的转换结论。", "en": "Takeda's DailyMed label describes lansoprazole as a proton-pump inhibitor that is converted to an active form in the acidic environment of the parietal cell and inhibits H+/K+-ATPase. This only explains a pharmacologic pathway; it does not provide an individual timing, strength, duration or conversion conclusion with another acid-suppressing medicine." }, "checks": [ { "zh": "与埃索美拉唑或奥美拉唑同属质子泵抑制剂，并不证明可以同日叠加、隔日轮换、互相代替或按相同 mg 使用。每个产品的剂型、强度、用途、市场和完整药单必须由专业人员核对。", "en": "Sharing the proton-pump-inhibitor class with esomeprazole or omeprazole does not prove that medicines can be added on the same day, alternated on different days, substituted or used at the same mg. Dosage form, strength, use, market and complete medicine list for every product need professional review." }, { "zh": "机制不回答 SoluTab、胶囊或其他口服产品能否打开、咀嚼、研碎、分片或混合，也不替代准确产品的现行标签。", "en": "Mechanism does not answer whether SoluTab, a capsule or another oral product can be opened, chewed, crushed, split or mixed, and it does not replace the current label for the exact product." }, { "zh": "症状缓解或反复并不能从机制中推导出自我加减、长期续用或改用另一种产品。涉及持续不适、出血警示症状或多药并用时，应使用当地专业支持。", "en": "Symptom relief or recurrence cannot be used to derive self-adjustment, long-term continuation or a change to another product from mechanism. With persistent symptoms, bleeding-warning symptoms or multiple medicines, use local professional support." } ], "source": { "id": "src_fe786172b22ae19e", "label": "DailyMed（NLM）：PREVACID / PREVACID SoluTab 当前美国公开标签（Takeda；页面 2025-07 更新，处方信息 2025-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=71ba78cb-7e46-43eb-9425-fa130f537f84", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Prevacid", "generic": "兰索拉唑", "dosageFormClass": "30 mg 延迟释放胶囊；15 mg、30 mg 延迟释放口崩片（DailyMed 2025-03 公开标签所列）" }, "labelSource": { "id": "src_fe786172b22ae19e", "label": "DailyMed（NLM）：PREVACID / PREVACID SoluTab 当前美国公开标签（Takeda，2025-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=71ba78cb-7e46-43eb-9425-fa130f537f84", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_fe786172b22ae19e", "label": "DailyMed（NLM）：PREVACID / PREVACID SoluTab 当前美国公开标签（Takeda，2025-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=71ba78cb-7e46-43eb-9425-fa130f537f84", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_105e50cc8ece5018", "label": "FDA：PREVACID / PREVACID SoluTab 2014 美国标签档案（NDA 020406 / 021428）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021428s028lbl020406s081lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 Takeda PREVACID / PREVACID SoluTab 2025-03 美国公开标签列示 30 mg 延迟释放胶囊，以及 15 mg、30 mg 延迟释放口崩片，并标示美国初始批准年份为 1995。页面将三张官方包装面板与各自 NDC、剂型、每单位标示量及包装分开对应；不据此推定其他市场的批准、原研关系、供应、价格或可售资格。", "history": "“延迟释放”与“口崩”描述的是准确制剂的产品身份，不是自行改变、互换、叠加或按相同 mg 换算的依据。当前标签还明确，PREVACID 15 mg 胶囊并非 Takeda 当前在美国销售的规格；它不能与 15 mg SoluTab 混作同一产品。胶囊和 SoluTab 的操作规则也不同，须逐项回到准确市场、规格与现行标签核对。", "sourceDocuments": [ { "id": "src_fe786172b22ae19e", "label": "DailyMed（NLM）：PREVACID / PREVACID SoluTab 当前美国公开标签（Takeda，2025-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=71ba78cb-7e46-43eb-9425-fa130f537f84", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_105e50cc8ece5018", "label": "FDA：PREVACID / PREVACID SoluTab 2014 美国标签档案（NDA 020406 / 021428）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021428s028lbl020406s081lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020406 / 021428", "approvalTimeline": [ { "date": "1995", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1995。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1995. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_105e50cc8ece5018", "label": "FDA: PREVACID label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021428s028lbl020406s081lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2014", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2014 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2014 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_105e50cc8ece5018", "label": "FDA: PREVACID label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021428s028lbl020406s081lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/prevacid/", "en": "https://origindrug.com/en/drugs/prevacid/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }