{ "id": "clopidogrel-plavix", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "Plavix", "generic": "氯吡格雷", "aliases": [ "波立维", "波立维®", "硫酸氢氯吡格雷片", "Clopidogrel Bisulfate Tablets", "clopidogrel", "clopidogrel bisulfate" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "波立维®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_772528a694d31352", "label": "Sanofi China：波立维产品公开页面", "url": "https://www.sanofi.cn/zh/your-health/products/plavix", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 DailyMed 当前公开 PLAVIX 标签（SPL v5，2025-05-30 生效）列出 75 mg 瓶装与 300 mg 泡罩板纸盒；中国大陆赛诺菲当前产品页分别列出进口与地产波立维® 75 mg 片剂，并链接 2025-05-22 进口说明书与 2025-09-01 国产说明书。三个市场/供应路径须按准确包装和说明书分别核对。", "dosageFormClass": "PLAVIX／波立维硫酸氢氯吡格雷薄膜衣口服片：美国 75 mg、300 mg；中国大陆进口与国产产品页均列示 75 mg", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1997（美国初始批准）", "archiveSponsorText": "Sanofi-Aventis U.S. LLC（美国当前公开标签）；赛诺菲中国官方产品页及两份有日期说明书" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "Plavix", "PLAVIX", "波立维", "波立维®", "氯吡格雷", "硫酸氢氯吡格雷片", "PLAVIX 75 mg", "波立维 75 mg", "PLAVIX 300 mg" ], "excludedProductCues": [ "多立维", "多立维®", "CoPlavix", "氯吡格雷阿司匹林片", "clopidogrel aspirin" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-plavix-tablet-75mg-ndc-0024-1171-90", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v5，2025-06-11 发布", "en": "DailyMed SPL v5, published 11 Jun 2025" }, "dosageForm": { "zh": "PLAVIX 氯吡格雷薄膜衣口服片", "en": "PLAVIX clopidogrel film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0024-1171-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 75 mg；90 片瓶装", "en": "75 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=de8b0b67-eb25-4684-83b5-7ad785314227&name=de8b0b67-eb25-4684-83b5-7ad785314227-10.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯吡格雷", "en": "clopidogrel" }, "value": 75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数、停药或换药规则", "en": "labelled amount per tablet; not an individual's tablet count, interruption or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "90 片瓶装", "en": "90-tablet bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-20", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形、双凸薄膜衣片", "en": "round biconvex film-coated tablet" }, "imprint": "75 / 1171", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3e070dd8ebe91314", "label": "DailyMed（NLM）：PLAVIX 氯吡格雷当前美国公开标签（Sanofi-Aventis；2025-05-30 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de8b0b67-eb25-4684-83b5-7ad785314227", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-plavix-tablet-300mg-ndc-0024-1332-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v5，2025-05-30 生效", "en": "DailyMed SPL v5, effective 30 May 2025" }, "dosageForm": { "zh": "PLAVIX 氯吡格雷薄膜衣口服片", "en": "PLAVIX clopidogrel film-coated oral tablet" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0024-1332-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 300 mg；30 片泡罩板纸盒", "en": "300 mg per tablet; 30-tablet blister-card carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=de8b0b67-eb25-4684-83b5-7ad785314227-11.jpg&setid=de8b0b67-eb25-4684-83b5-7ad785314227", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯吡格雷", "en": "clopidogrel" }, "value": 300, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是用多片 75 mg 自行拼量、负荷或换算的许可", "en": "labelled amount per tablet; not permission to assemble a loading amount or conversion from multiple 75 mg tablets" } } ], "concentration": null, "container": { "typeCode": "blister_carton", "typeLabel": { "zh": "泡罩板纸盒", "en": "blister-card carton" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/盒", "en": "tablets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/盒", "en": "tablets per carton" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "长椭圆形薄膜衣片", "en": "oblong film-coated tablet" }, "imprint": "300 / 1332", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3e070dd8ebe91314", "label": "DailyMed（NLM）：PLAVIX 300 mg、NDC 0024-1332-30、30 片泡罩板纸盒美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de8b0b67-eb25-4684-83b5-7ad785314227", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "cn-plavix-clopidogrel-bisulfate-tablet-75mg-domestic-h20056410", "marketCode": "CN", "labelVersion": { "zh": "赛诺菲中国国产说明书，2025-09-01 修订", "en": "Sanofi China locally produced leaflet, revised 1 Sep 2025" }, "dosageForm": { "zh": "波立维® 硫酸氢氯吡格雷薄膜衣片（国产）", "en": "PLAVIX clopidogrel bisulfate film-coated tablet (locally produced in China)" }, "route": { "zh": "口服（中国大陆说明书产品身份字段）", "en": "oral (Mainland China leaflet product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NMPA approval No. H20056410", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯吡格雷 75 mg；硬双铝包装 7、14、28 或 90 片/盒", "en": "Clopidogrel 75 mg per tablet; hard double-aluminium packs of 7, 14, 28 or 90 tablets per carton" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯吡格雷（以硫酸氢氯吡格雷提供）", "en": "clopidogrel (provided as clopidogrel bisulfate)" }, "value": 75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片中国说明书标示量；不是个人片数、负荷、停用或换药指令", "en": "Mainland China leaflet amount per tablet; not an individual's tablet count, loading, interruption or switching instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_11bf819ee616bfaa", "label": "赛诺菲中国：波立维®国产硫酸氢氯吡格雷片说明书（75 mg；H20056410；2025-09-01 修订）", "url": "https://www.sanofi.cn/assets/dot-cn/pages/docs/products/prescription-products/20250901-Plavix-tab-75mg-LMP-PI-update-chp2025-transfered.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "cn-plavix-clopidogrel-bisulfate-tablet-75mg-imported-hj20171237-hj20171238", "marketCode": "CN", "labelVersion": { "zh": "赛诺菲中国进口说明书，2025-05-22 修订", "en": "Sanofi China imported-product leaflet, revised 22 May 2025" }, "dosageForm": { "zh": "波立维® PLAVIX® 硫酸氢氯吡格雷薄膜衣片（进口）", "en": "PLAVIX clopidogrel bisulfate film-coated tablet (imported into China)" }, "route": { "zh": "口服（中国大陆说明书产品身份字段）", "en": "oral (Mainland China leaflet product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NMPA approval No. HJ20171237 (small pack) / HJ20171238 (large pack)", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯吡格雷 75 mg；双铝泡罩包装 7、28 或 90 片/盒", "en": "Clopidogrel 75 mg per tablet; double-aluminium blister packs of 7, 28 or 90 tablets per carton" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯吡格雷（以硫酸氢氯吡格雷提供）", "en": "clopidogrel (provided as clopidogrel bisulfate)" }, "value": 75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片中国说明书标示量；不是个人片数、负荷、停用或换药指令", "en": "Mainland China leaflet amount per tablet; not an individual's tablet count, loading, interruption or switching instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_3401fd02b94e49fe", "label": "赛诺菲中国：波立维®进口硫酸氢氯吡格雷片说明书（75 mg；HJ20171237/HJ20171238；2025-05-22 修订）", "url": "https://www.sanofi.cn/assets/dot-cn/pages/docs/products/prescription-products/20250522-plavix-tab-75mg-LRP-PI-MAHD-variation-transferred.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-plavix-tablet-75mg-ndc-0024-1171-90", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=de8b0b67-eb25-4684-83b5-7ad785314227&name=de8b0b67-eb25-4684-83b5-7ad785314227-10.jpg", "alt": "PLAVIX 氯吡格雷在美国 DailyMed Sanofi 当前公开标签中的 75 mg、NDC 0024-1171-90、90 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v5（2025-06-11 发布）", "presentation": "PLAVIX 氯吡格雷薄膜衣片：每片 75 mg，NDC 0024-1171-90，90 片瓶装展示面。", "notice": "此图只对应美国 DailyMed 当前标签中 PLAVIX、氯吡格雷 75 mg、NDC 0024-1171-90 与 90 片瓶装。它只帮助核对品牌、通用名、每片标示量、片剂、包装数量与来源；不用于鉴定真伪，也不证明 300 mg、其他包装、其他市场、当前可得性、原研身份、可替代性或任何个人的片数、联用、开始、停用、围手术期处理或换药方案。", "source": { "id": "src_3e070dd8ebe91314", "label": "DailyMed（NLM）：PLAVIX 氯吡格雷当前美国公开标签（Sanofi-Aventis；SPL v5，2025-06-11 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de8b0b67-eb25-4684-83b5-7ad785314227", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "PLAVIX／波立维说明书放大阅读：先分市场、75/300 mg 与单方/复方", "en": "PLAVIX / 波立维 label reading: separate market, 75/300 mg and single-ingredient/combination products" }, "summary": { "zh": "美国当前 PLAVIX 标签列出 75 mg 与 300 mg 两种片剂；赛诺菲中国当前产品页把进口与地产波立维都列为 75 mg 片剂，并各有不同说明书、包装和批准文号。多立维另含阿司匹林，是单独复方产品。本模块只帮助读懂这些身份和安全边界，不生成个人片数、负荷量、停药、手术、联用、换药或基因检测方案。", "en": "The current U.S. PLAVIX label lists 75 mg and 300 mg tablets. Sanofi China's current product page lists both imported and locally produced 波立维 75 mg tablets, each with a distinct leaflet, pack description and approval number. CoPlavix / 多立维 also contains aspirin and is a separate combination product. This module explains product identity and safety boundaries; it does not generate an individual tablet count, loading amount, interruption, procedure, combination, switching or genetic-testing plan." }, "checks": [ { "zh": "先看手上药盒属于美国 PLAVIX 75 mg／300 mg、中国进口波立维 75 mg，还是中国地产波立维 75 mg。相同品牌与毫克数不能抹去批准文号、包装片数、上市许可持有人和说明书日期差异；300 mg 也不是网页允许用多片 75 mg 自行拼出的答案。", "en": "First identify whether the pack is U.S. PLAVIX 75 mg/300 mg, imported China-market 波立维 75 mg, or locally produced China-market 波立维 75 mg. A shared brand and milligram number do not erase approval-number, pack-count, holder or leaflet-date differences, and 300 mg is not webpage permission to assemble an amount from multiple 75 mg tablets." }, { "zh": "多立维®／CoPlavix 每片还含阿司匹林，属于另一份复方药档案。看到“氯吡格雷 75 mg”不能把单方波立维和氯吡格雷/阿司匹林复方视为同一种药，也不能在药单上自行叠加、替换或补用。", "en": "CoPlavix / 多立维 contains aspirin as an additional ingredient and is a separate combination product. Seeing ‘clopidogrel 75 mg’ does not make single-ingredient PLAVIX and a clopidogrel/aspirin combination the same medicine, and it does not permit self-combination, substitution or make-up use." }, { "zh": "美国和中国说明书均讨论 CYP2C19 相关代谢差异；这不是“人人都应做全基因筛查”的结论。是否需要做哪一种检测、怎样解释已有结果、是否影响选择，必须结合适应症、事件史、目标市场说明书和完整药单由负责团队判断。", "en": "The U.S. and China leaflets discuss CYP2C19-related metabolic differences. This is not a conclusion that everyone needs whole-genome screening. Whether a test is needed, which test, how an existing result should be interpreted and whether it changes a choice require the indication, event history, target-market label and complete medicine list to be assessed by the responsible team." }, { "zh": "美国当前标签明确把奥美拉唑或艾司奥美拉唑列为需要避免同用的 CYP2C19 抑制剂线索，并指出间隔 12 小时也不能消除所观察到的影响。看到这条信息应带上胃药和完整药单请药师或开方团队处理，不能自行突然停胃药、停波立维、改时间或换成另一种药。", "en": "The current U.S. label explicitly identifies omeprazole or esomeprazole as CYP2C19-inhibitor co-medication cues to avoid and notes that separating administration by 12 hours did not remove the observed effect. This should prompt review of the stomach medicine and full list by a pharmacist or prescriber, not abrupt self-stopping, timing changes or substitution of either medicine." }, { "zh": "与阿司匹林、华法林或其他抗凝/抗血小板药、布洛芬/萘普生等 NSAID 止痛药、SSRI/SNRI 抗抑郁药同在药单时，标签提示出血风险需要优先核对。黑便、呕血、持续难止的出血，或跌倒/头部受伤后出现不适，应使用当地紧急医疗渠道；不要等待网页判断。", "en": "When aspirin, warfarin or another anticoagulant/antiplatelet medicine, an NSAID pain medicine such as ibuprofen/naproxen, or an SSRI/SNRI is on the same list, the label identifies bleeding risk for priority review. Black stool, vomiting blood, bleeding that will not stop, or symptoms after a fall/head injury require local urgent care; do not wait for a webpage to decide." }, { "zh": "准备手术、拔牙或其他侵入性操作时，不要自己照搬说明书里的天数停药。PLAVIX 标签同时警示停用会增加心血管事件风险；是否暂停、何时暂停和何时恢复必须由开方与操作团队给出针对个人和具体操作的指示。", "en": "Before surgery, dental extraction or another invasive procedure, do not copy a number of interruption days from the label yourself. The PLAVIX label also warns that discontinuation increases cardiovascular-event risk; whether to interrupt, when to do so and when to resume require instructions for the individual and specific procedure from the prescribing and procedural teams." } ], "source": { "id": "src_3e070dd8ebe91314", "label": "DailyMed（NLM）：PLAVIX 氯吡格雷当前美国公开标签（Sanofi-Aventis；2025-05-30 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de8b0b67-eb25-4684-83b5-7ad785314227", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "氯吡格雷怎样起作用：它经活性代谢物影响血小板 P2Y12 受体", "en": "How clopidogrel works: its active metabolite acts on platelet P2Y12 receptors" }, "summary": { "zh": "FDA 的 PLAVIX 处方信息描述：氯吡格雷的活性代谢物不可逆地结合血小板上的 P2Y12 类 ADP 受体，从而抑制血小板活化和聚集。该机制帮助读懂“抗血小板”这几个字；它不能决定个人是否该开始、停用、联用、围手术期怎样处理或何时恢复。", "en": "FDA's PLAVIX prescribing information describes clopidogrel's active metabolite as binding irreversibly to P2Y12-class ADP receptors on platelets, inhibiting platelet activation and aggregation. This helps explain “antiplatelet”; it cannot decide whether an individual should start, stop, combine medicines, manage a procedure or resume treatment." }, "checks": [ { "zh": "“血小板聚集”可理解为血小板彼此黏连形成血栓过程的一部分。机制说明的是一个受体通路，并不等于所有出血、胸痛、卒中样症状或即将手术的情况都能靠网页自行处理。", "en": "“Platelet aggregation” can be understood as part of the process in which platelets stick together. The mechanism describes one receptor pathway; it does not mean bleeding, chest pain, stroke-like symptoms or an upcoming procedure can be self-managed from a webpage." }, { "zh": "标签说明氯吡格雷需要经 CYP450 酶形成活性代谢物，并特别提到 CYP2C19 相关差异。它不表示每个人都应自行做检测或自行根据结果换药；已有检测报告应由专业人员连同适应症、完整药单与当地现行标签解释。", "en": "The label says clopidogrel requires CYP450 metabolism to form its active metabolite and specifically identifies CYP2C19-related variation. It does not mean everyone should self-order testing or change medicines based on a result; an existing report needs professional interpretation with the indication, complete medicine list and current local label." }, { "zh": "与阿司匹林、抗凝药、止痛药、草本、胃药或其他“防血栓”产品一起使用时，风险与收益不能仅凭“机制相同或不同”判断。尤其在异常出血、跌倒或头部受伤、手术和牙科操作前后，应按负责团队的具体指示处理，不能自行漏服、补服、叠加或停用。", "en": "With aspirin, anticoagulants, pain medicines, herbs, stomach medicines or another “blood-thinning” product, risk and benefit cannot be judged merely from whether mechanisms are the same or different. Especially with unusual bleeding, a fall or head injury, and before or after surgery or dental work, follow the responsible team's specific instructions rather than self-missing, making up, combining or stopping doses." } ], "source": { "id": "src_3e070dd8ebe91314", "label": "DailyMed（NLM）：PLAVIX 氯吡格雷当前美国公开标签（Mechanism of Action；2025-05-30 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de8b0b67-eb25-4684-83b5-7ad785314227", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Plavix", "generic": "氯吡格雷", "dosageFormClass": "PLAVIX／波立维硫酸氢氯吡格雷薄膜衣口服片：美国 75 mg、300 mg；中国大陆进口与国产产品页均列示 75 mg" }, "labelSource": { "id": "src_3e070dd8ebe91314", "label": "DailyMed（NLM）：PLAVIX 氯吡格雷当前美国公开标签（Sanofi-Aventis；2025-05-30 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de8b0b67-eb25-4684-83b5-7ad785314227", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_3e070dd8ebe91314", "label": "DailyMed（NLM）：PLAVIX 氯吡格雷当前美国公开标签（Sanofi-Aventis；2025-05-30 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de8b0b67-eb25-4684-83b5-7ad785314227", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "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": "2026-08-30", "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_11bf819ee616bfaa", "label": "赛诺菲中国：波立维®国产硫酸氢氯吡格雷片说明书（2025-09-01 修订）", "url": "https://www.sanofi.cn/assets/dot-cn/pages/docs/products/prescription-products/20250901-Plavix-tab-75mg-LMP-PI-update-chp2025-transfered.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "public_product_record_verified", "authority": { "zh": "公开产品记录来源", "en": "Public product-record source" }, "market": { "zh": "以原始文件为准", "en": "See original document" }, "recordType": { "zh": "公开产品记录", "en": "Public product record" }, "reviewedAt": "2026-08-30", "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_3401fd02b94e49fe", "label": "赛诺菲中国：波立维®进口硫酸氢氯吡格雷片说明书（2025-05-22 修订）", "url": "https://www.sanofi.cn/assets/dot-cn/pages/docs/products/prescription-products/20250522-plavix-tab-75mg-LRP-PI-MAHD-variation-transferred.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "public_product_record_verified", "authority": { "zh": "公开产品记录来源", "en": "Public product-record source" }, "market": { "zh": "以原始文件为准", "en": "See original document" }, "recordType": { "zh": "公开产品记录", "en": "Public product record" }, "reviewedAt": "2026-08-30", "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": "2026-08-30", "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": [ { "id": "fda-pharmacogenomic-label-record-clopidogrel", "issuedAt": "2025-12", "status": "fda_pharmacogenomic_label_record", "title": { "zh": "FDA 药物基因组标签记录：clopidogrel 与 CYP2C19", "en": "FDA pharmacogenomic label record: clopidogrel and CYP2C19" }, "summary": { "zh": "FDA 的药物基因组标签表将 clopidogrel（Plavix）列入与 CYP2C19 相关的标签信息项目。该表是美国监管机构对标签中基因组信息位置的索引，不等于每位使用者都需要筛查、已检测者就应自行改剂量，或可自行换成另一种药。是否检测、怎样解释结果及与其他药同用的问题，必须连同准确产品、适应症、现行标签和完整用药清单由开方团队或药师核对。", "en": "FDA’s Table of Pharmacogenomic Biomarkers in Drug Labeling lists clopidogrel (Plavix) with CYP2C19-related labeling information. The table is a U.S. regulator index to where genomic information appears in labeling; it does not mean every user needs screening, that a tested person should self-change a dose, or that another medicine may be substituted independently. Whether to test, how to interpret a result and how it relates to other medicines must be reviewed with the exact product, indication, current label and complete medicine list by the prescribing team or pharmacist." }, "source": { "id": "src_9f4d37bf0406cd2b", "label": "FDA：药品标签中的药物基因组生物标志物表", "url": "https://www.fda.gov/drugs/science-and-research-drugs/table-pharmacogenomic-biomarkers-drug-labeling/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "pharmacogenomic_label_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-2015-clopidogrel-plavix-long-term-treatment-safety-communication", "issuedAt": "2015-11-06", "status": "fda_drug_safety_communication", "title": { "zh": "FDA 药物安全通讯：Plavix／氯吡格雷长期治疗的死亡风险审查", "en": "FDA Drug Safety Communication: review of mortality risk with long-term Plavix/clopidogrel treatment" }, "summary": { "zh": "FDA 于 2015-11-06 发布美国药物安全通讯，说明其对 DAPT 试验及其他长期临床试验的复核未显示氯吡格雷会增加或降低心脏病患者或高风险人群的总体死亡风险，也未提示增加癌症或癌症死亡风险。该通讯讨论的是美国、特定试验背景下的长期抗血小板治疗证据；它不等于任何个人的出血、血栓、癌症、疗程、是否需要基因检测或联合用药判断，也不支持自行停用 Plavix／氯吡格雷或自行与阿司匹林、抗凝药、止痛药或其他产品轮换、叠加或替换。出现出血、胸痛、神经系统症状或其他急性不适时，应使用当地紧急医疗支持，并由开方团队或药师连同完整药单核对。", "en": "In a U.S. Drug Safety Communication issued on 2015-11-06, FDA said its review of the DAPT trial and other long-term clinical trials did not show that clopidogrel increases or decreases overall risk of death in people with, or at risk for, heart disease, and did not suggest increased cancer or cancer-death risk. The communication concerns evidence for long-term antiplatelet treatment in a specific U.S. trial context. It cannot determine an individual’s bleeding, clotting, cancer, treatment duration, need for genetic testing or co-medication plan, and it does not support self-stopping Plavix/clopidogrel or self-alternating, adding or replacing it with aspirin, anticoagulants, pain medicines or another product. Bleeding, chest pain, neurological symptoms or another acute concern needs local emergency support and review of the complete medicine list with the prescribing team or pharmacist." }, "source": { "id": "src_aed7d4adaf8a3f21", "label": "香港卫生署药物办公室：转载 FDA 2015-11-06 Plavix（clopidogrel）长期治疗安全通讯的官方安全警示档案", "url": "https://www.drugoffice.gov.hk/eps/news/showNews/The%2BUnited%2BStates%3A%2BDrug%2BSafety%2BCommunication%3A%2BFDA%2Breview%2Bfinds%2Blong-term%2Btreatment%2Bwith%2Bblood-thinning%2Bmedicine%2BPlavix%2B%28clopidogrel%29%2Bdoes%2Bnot%2Bchange%2Br/pharmaceutical_trade/2015-11-07/en/25341.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "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": "PLAVIX／波立维是氯吡格雷口服薄膜衣片的市场品牌档案。美国当前标签有 75 mg 与 300 mg 两种准确产品呈现；中国大陆赛诺菲产品页同时列出进口和地产 75 mg 片剂，且两份说明书的包装与批准文号不同。页面先帮助核对品牌、通用名、每片标示量、市场、包装和说明书日期；不把 300 mg 当成可自行用多片 75 mg 拼出的方案，也不根据基因、相互作用或手术计划替个人停药、换药或安排片数。", "history": "FDA 的 PLAVIX 美国品牌档案始于 1997 年；DailyMed 当前公开标签生效于 2025-05-30。赛诺菲中国当前产品页把波立维®分别列为进口与地产 75 mg 片剂：2025-09-01 国产说明书列国药准字 H20056410 与 7/14/28/90 片硬双铝包装；2025-05-22 进口说明书列国药准字 HJ20171237/HJ20171238 与 7/28/90 片双铝泡罩包装。多立维®另含阿司匹林，是另一份复方产品，不能并入本单方档案。", "sourceDocuments": [ { "id": "src_3e070dd8ebe91314", "label": "DailyMed（NLM）：PLAVIX 氯吡格雷当前美国公开标签（Sanofi-Aventis；2025-05-30 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de8b0b67-eb25-4684-83b5-7ad785314227", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_772528a694d31352", "label": "赛诺菲中国：波立维®进口/地产 75 mg 产品页", "url": "https://www.sanofi.cn/zh/your-health/products/plavix", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_11bf819ee616bfaa", "label": "赛诺菲中国：波立维®国产硫酸氢氯吡格雷片说明书（2025-09-01 修订）", "url": "https://www.sanofi.cn/assets/dot-cn/pages/docs/products/prescription-products/20250901-Plavix-tab-75mg-LMP-PI-update-chp2025-transfered.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_3401fd02b94e49fe", "label": "赛诺菲中国：波立维®进口硫酸氢氯吡格雷片说明书（2025-05-22 修订）", "url": "https://www.sanofi.cn/assets/dot-cn/pages/docs/products/prescription-products/20250522-plavix-tab-75mg-LRP-PI-MAHD-variation-transferred.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_da4e2fd483abd468", "label": "赛诺菲中国：多立维®氯吡格雷/阿司匹林复方产品页（单方 PLAVIX 的身份排除项）", "url": "https://www.sanofi.cn/zh/your-health/products/coplavix", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA：PLAVIX NDA 020839 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 020839", "approvalTimeline": [ { "date": "1997", "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: 1997。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: 1997. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_66da32e920670e55", "label": "FDA: PLAVIX label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020839s078lbl.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": "2022", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2022 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 2022 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_66da32e920670e55", "label": "FDA: PLAVIX label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020839s078lbl.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": [ { "target": { "id": "nexium", "brand": "Nexium", "generic": "埃索美拉唑", "canonicalUrls": { "zh": "https://origindrug.com/drugs/nexium/", "en": "https://origindrug.com/en/drugs/nexium/" } }, "title": { "zh": "与 NEXIUM／埃索美拉唑同在药单上时：先做完整清单核对", "en": "When NEXIUM / esomeprazole is on the same list: review the complete list first" }, "summary": { "zh": "PLAVIX 的美国公开标签将奥美拉唑或埃索美拉唑列为需要核对的联用线索。本卡片只提示把所有实际药盒、非处方药和补充剂交给药师或开方团队复核；它不判断能否同服，也不建议自行停用、错开时间、替换或调整任何一种药。", "en": "The U.S. PLAVIX public label names omeprazole or esomeprazole as co-medication cues that need review. This card only signals that every actual pack, OTC product and supplement should be reviewed by a pharmacist or prescriber; it does not decide co-use or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_3e070dd8ebe91314", "label": "DailyMed（NLM）：PLAVIX 氯吡格雷当前美国公开标签（Sanofi-Aventis；SPL v5，2025-06-11 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de8b0b67-eb25-4684-83b5-7ad785314227", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "review_complete_medicine_list_no_self_directed_change" } ], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/clopidogrel-plavix/", "en": "https://origindrug.com/en/drugs/clopidogrel-plavix/" }, "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." ] }