{ "id": "micardis", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-28", "status": "published_traceable_archive" }, "names": { "brand": "Micardis", "generic": "替米沙坦", "aliases": [ "telmisartan", "替米沙坦", "替米沙坦片", "美卡素" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "美卡素®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_daf163775527c72b", "label": "江阴市人民政府：2024 年常用药品信息中的美卡素／替米沙坦片 80 mg 记录", "url": "https://www.jiangyin.gov.cn/doc/2024/03/26/1217423.shtml", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "government_medicine_listing", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-12", "reviewedAt": "2026-09-12" } } }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国公开处方药标签档案（DailyMed 2025-05 版本）", "dosageFormClass": "口服片剂：20 mg、40 mg、80 mg（本档案所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1998（DailyMed 美国公开标签所列初始批准）", "archiveSponsorText": "Boehringer Ingelheim Pharmaceuticals, Inc. / DailyMed（NLM）公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-micardis-20mg-ndc-0597-0039-37", "marketCode": "US", "labelVersion": { "zh": "DailyMed 2025-05；标签文字规格，不代表当前供应", "en": "DailyMed May 2025; labelled package text, not current availability" }, "dosageForm": { "zh": "口服片剂", "en": "oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0597-0039-37", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "20 mg／片；30 片（3 × 10 泡罩卡）", "en": "20 mg per tablet; 30 tablets (3 × 10 blister cards)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=micardis-05.jpg&archiveid=890860", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "替米沙坦", "en": "telmisartan" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量", "en": "per labelled tablet" } } ], "concentration": null, "container": { "typeCode": "carton_with_blister_cards", "typeLabel": { "zh": "含 3 张泡罩卡的纸盒", "en": "carton with 3 blister cards" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片", "en": "tablets" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片／盒（3 × 10 泡罩卡）", "en": "tablets per carton (3 × 10 blister cards)" } }, "physicalClues": { "color": { "zh": "白色或类白色", "en": "white or off-white" }, "shape": { "zh": "圆形、无包衣", "en": "round, uncoated" }, "imprint": { "zh": "BI 标志 / 50H", "en": "BI logo / 50H" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e51f7c3a24832b66", "label": "DailyMed（NLM）：MICARDIS 替米沙坦公开标签（Boehringer Ingelheim，2025-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfb9309f-e0df-4a55-9542-0e869fce05fb", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "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-micardis-40mg-ndc-0597-0040-37", "marketCode": "US", "labelVersion": { "zh": "DailyMed 2025-05；标签文字规格，不代表当前供应", "en": "DailyMed May 2025; labelled package text, not current availability" }, "dosageForm": { "zh": "口服片剂", "en": "oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0597-0040-37", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "40 mg／片；30 片（3 × 10 泡罩卡）", "en": "40 mg per tablet; 30 tablets (3 × 10 blister cards)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=micardis-06.jpg&archiveid=890860", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "替米沙坦", "en": "telmisartan" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量", "en": "per labelled tablet" } } ], "concentration": null, "container": { "typeCode": "carton_with_blister_cards", "typeLabel": { "zh": "含 3 张泡罩卡的纸盒", "en": "carton with 3 blister cards" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片", "en": "tablets" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片／盒（3 × 10 泡罩卡）", "en": "tablets per carton (3 × 10 blister cards)" } }, "physicalClues": { "color": { "zh": "白色或类白色", "en": "white or off-white" }, "shape": { "zh": "椭圆形、无包衣", "en": "oblong, uncoated" }, "imprint": { "zh": "BI 标志 / 51H", "en": "BI logo / 51H" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e51f7c3a24832b66", "label": "DailyMed（NLM）：MICARDIS 替米沙坦公开标签（Boehringer Ingelheim，2025-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfb9309f-e0df-4a55-9542-0e869fce05fb", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "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-micardis-80mg-ndc-0597-0041-37", "marketCode": "US", "labelVersion": { "zh": "DailyMed 2025-05；标签文字规格，不代表当前供应", "en": "DailyMed May 2025; labelled package text, not current availability" }, "dosageForm": { "zh": "口服片剂", "en": "oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0597-0041-37", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "80 mg／片；30 片（3 × 10 泡罩卡）", "en": "80 mg per tablet; 30 tablets (3 × 10 blister cards)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=micardis-07.jpg&archiveid=890860", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "替米沙坦", "en": "telmisartan" }, "value": 80, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量", "en": "per labelled tablet" } } ], "concentration": null, "container": { "typeCode": "carton_with_blister_cards", "typeLabel": { "zh": "含 3 张泡罩卡的纸盒", "en": "carton with 3 blister cards" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片", "en": "tablets" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片／盒（3 × 10 泡罩卡）", "en": "tablets per carton (3 × 10 blister cards)" } }, "physicalClues": { "color": { "zh": "白色或类白色", "en": "white or off-white" }, "shape": { "zh": "椭圆形、无包衣", "en": "oblong, uncoated" }, "imprint": { "zh": "BI 标志 / 52H", "en": "BI logo / 52H" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e51f7c3a24832b66", "label": "DailyMed（NLM）：MICARDIS 替米沙坦公开标签（Boehringer Ingelheim，2025-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfb9309f-e0df-4a55-9542-0e869fce05fb", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "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": "us-micardis-20mg-ndc-0597-0039-37", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=micardis-05.jpg&archiveid=890860", "alt": "MICARDIS 20 mg、30 片（3 × 10 泡罩卡）、NDC 0597-0039-37 在美国 DailyMed 公开标签中的纸盒展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 2025-05 公开标签；纸盒图稿标示 2022", "presentation": "MICARDIS（telmisartan）20 mg：30 片（3 × 10 泡罩卡），NDC 0597-0039-37", "notice": "此图只对应美国 DailyMed 公开标签中 MICARDIS 20 mg、30 片（3 × 10 泡罩卡）、NDC 0597-0039-37 的纸盒展示面。它帮助核对品牌、通用名、每片强度、包装与来源；不用于鉴定真伪，也不证明 40 mg、80 mg、其他市场、当前供应、目标市场批准、原研身份或个人用药方案。", "source": { "id": "src_e51f7c3a24832b66", "label": "DailyMed（NLM）：MICARDIS 替米沙坦 20 mg、30 片（3 × 10 泡罩卡）美国公开标签纸盒面板（Boehringer Ingelheim，2025-05 标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfb9309f-e0df-4a55-9542-0e869fce05fb", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "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": "MICARDIS 说明书放大阅读：20、40、80 mg 先用于确认准确片剂", "en": "MICARDIS label reading: 20, 40 and 80 mg first identify the exact tablet" }, "summary": { "zh": "本模块以美国 DailyMed 公开标签为阅读入口，帮助核对 MICARDIS、替米沙坦、每片标示量、口服片剂和目标市场。它不提供任何人的片数、开始/停用、联用、转换或血压处理方案。", "en": "This module uses the U.S. DailyMed public label to check MICARDIS, telmisartan, stated amount per tablet, oral tablets and the target market. It does not provide an individual's tablet count, start/stop, combination, switching or blood-pressure-management plan." }, "checks": [ { "zh": "20 mg、40 mg、80 mg 是美国标签所列每片标示强度，不是网页给任何人计算今天应服几片的答案。应同时核对 MICARDIS、替米沙坦、每片强度、口服片剂、实际包装和目标市场。", "en": "20 mg, 40 mg and 80 mg are labelled strengths per tablet in the U.S. label, not a web answer to how many tablets anyone should take today. Check MICARDIS, telmisartan, strength per tablet, oral tablet, actual pack and target market together." }, { "zh": "同为“降压药”、同属相关类别或包装数字相近，都不授权自行叠加、轮换、补用、掰开，或以另一种强度、剂型或产品替代。涉及任何变动时，应回到准确产品的现行标签、处方和药师/医生复核。", "en": "A shared blood-pressure description, related class or similar package number does not authorise self-combining, alternating, catch-up use, splitting or replacement with another strength, form or product. Any change must return to the current label, prescription and pharmacist/clinician review for the exact product." }, { "zh": "标签列有与其他血压药、利尿剂、含钾补充剂或代盐、NSAIDs、锂盐等有关的核对事项。正在使用心血管、肾脏、止痛、感冒或补充剂产品时，应把所有实际药盒与完整药单交由专业人员一起核对，不要因名称不同就推定可以安全合用。", "en": "The label contains checks involving other blood-pressure medicines, diuretics, potassium supplements or salt substitutes, NSAIDs and lithium. With cardiovascular, kidney, pain, cold or supplement products, have a professional review the actual packs and complete medicine list together; different names do not establish that co-use is safe." }, { "zh": "该标签含妊娠、低血压、肾功能和高钾相关警示。出现晕厥、明显虚弱、严重不适，或处于妊娠/备孕、脱水、肾脏问题等情形时，应及时使用当地医疗与开方团队渠道；网页不判断是否自行继续、停用或换药。", "en": "The label includes pregnancy, low-blood-pressure, kidney-function and high-potassium warnings. With fainting, marked weakness, a serious concern, or pregnancy/planning pregnancy, dehydration or kidney concerns, use local medical and prescribing-team pathways promptly; this page does not decide whether to self-continue, stop or switch." } ], "source": { "id": "src_e51f7c3a24832b66", "label": "DailyMed（NLM）：MICARDIS 替米沙坦公开标签（Boehringer Ingelheim，2025-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfb9309f-e0df-4a55-9542-0e869fce05fb", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "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": "替米沙坦怎样起作用：标签将其归为血管紧张素 II 受体阻断剂", "en": "How telmisartan works: the label classifies it as an angiotensin II receptor blocker" }, "summary": { "zh": "DailyMed 标签将 MICARDIS 描述为血管紧张素 II 受体（AT1 亚型）拮抗剂。它帮助解释药物类别与标签中的相互作用、妊娠、肾功能和高钾警示；不能由此判断个人血压原因、适用性、片数、联用或转换方案。", "en": "The DailyMed label describes MICARDIS as an angiotensin II receptor (AT1 subtype) antagonist. This helps explain the drug class and the label's interaction, pregnancy, kidney-function and high-potassium warnings; it cannot determine an individual's blood-pressure cause, suitability, tablet count, combination or switching plan." }, "checks": [ { "zh": "可以把 AT1 受体理解为血管紧张素 II 作用路径中的一个“接点”。这解释的是药理类别，不是对个人血压读数、症状、心肾状况或是否需要治疗的判断。", "en": "An AT1 receptor can be read as one ‘connection point’ in the angiotensin II pathway. This explains a pharmacologic class, not a judgement about an individual's blood-pressure reading, symptoms, heart/kidney status or need for treatment." }, { "zh": "共享“ARB”类别或都写有“降压”用途，不支持把 MICARDIS 与其他 ARB、ACE 抑制剂、利尿剂或任何心血管药自行叠加、轮换或互换。产品、剂型、既往反应、肾功能、血压记录和完整药单必须由专业人员一起核对。", "en": "A shared ARB class or blood-pressure wording does not support self-combining, alternating or substituting MICARDIS with another ARB, an ACE inhibitor, a diuretic or any cardiovascular medicine. Product, dosage form, prior reactions, kidney function, blood-pressure records and the complete medicine list require professional review together." }, { "zh": "机制页面也不能把“受体阻断”转换成对孕期、肾功能变化、脱水、头晕或新不适的个人处理建议。出现急性或严重不适时，应优先使用当地紧急医疗支持，而不是依据本页自行调整。", "en": "A mechanism page also cannot turn ‘receptor blockade’ into personal advice for pregnancy, kidney-function changes, dehydration, dizziness or a new concern. With an acute or serious issue, prioritise local urgent medical support rather than self-adjusting from this page." } ], "source": { "id": "src_e51f7c3a24832b66", "label": "DailyMed（NLM）：MICARDIS 替米沙坦公开标签（Clinical Pharmacology，2025-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfb9309f-e0df-4a55-9542-0e869fce05fb", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "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": "Micardis", "generic": "替米沙坦", "dosageFormClass": "口服片剂：20 mg、40 mg、80 mg（本档案所列）" }, "labelSource": { "id": "src_e51f7c3a24832b66", "label": "DailyMed（NLM）：MICARDIS 替米沙坦公开标签（Boehringer Ingelheim，2025-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfb9309f-e0df-4a55-9542-0e869fce05fb", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "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_e51f7c3a24832b66", "label": "DailyMed（NLM）：MICARDIS 替米沙坦公开标签（Boehringer Ingelheim，2025-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfb9309f-e0df-4a55-9542-0e869fce05fb", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "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_bf8aec96a9049f72", "label": "FDA：MICARDIS 2012 美国处方信息（NDA 020850）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020850s033lbl.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 MICARDIS（telmisartan）美国公开标签列示 20 mg、40 mg、80 mg 口服片剂，并列示美国初始批准年份为 1998。本页把三种强度各自对应的 30 片（3 × 10 泡罩卡）官方标签纸盒图、品牌、通用名、每片标示强度、剂型与原始标签并列，帮助核对准确产品；不据此生成个人片数、加减量、联用、转换、停药或血压处理方案。", "history": "本档案链接的 DailyMed 页面是美国公开标签阅读入口，页面所列包装商为 Boehringer Ingelheim Pharmaceuticals, Inc.。本页 20 mg、40 mg、80 mg 三张纸盒图分别对应同一公开标签中的准确 NDC 与 3 × 10 泡罩卡面板，仅用于核对这一美国标签产品，不作真伪鉴定，也不证明中国大陆或任何其他市场的当前批准、持有人、可获得性、价格、原研/仿制关系或可售资格；均须按目标市场的现行官方记录另行核验。", "sourceDocuments": [ { "id": "src_e51f7c3a24832b66", "label": "DailyMed（NLM）：MICARDIS 替米沙坦公开标签（Boehringer Ingelheim，2025-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfb9309f-e0df-4a55-9542-0e869fce05fb", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_bf8aec96a9049f72", "label": "FDA：MICARDIS 2012 美国处方信息（NDA 020850）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020850s033lbl.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 020850", "approvalTimeline": [ { "date": "1998", "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: 1998。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: 1998. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_e51f7c3a24832b66", "label": "DailyMed: MICARDIS public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfb9309f-e0df-4a55-9542-0e869fce05fb", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-05", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2025-05 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 2025-05 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_e51f7c3a24832b66", "label": "DailyMed: MICARDIS public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfb9309f-e0df-4a55-9542-0e869fce05fb", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "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/micardis/", "en": "https://origindrug.com/en/drugs/micardis/" }, "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." ] }