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法规知识库 · EMA 集中审评

Clopidogrel Viatris (previously Clopidogrel Taw Pharma)

clopidogrel besilate · EMEA/H/C/001189 · 已授权

仿制药

获批上市许可

2009-10-16

欧委会决定日

2025-12-12

持有人 / 申请人

Viatris Limited

终止日期字段

无

从产品到官方文件

文件记录

6

官方索引 6

EPAR / 审评

4

assessment / overview 等

产品信息

2

PI / presentations

其他

0

RMP / PIP 等

ATC:B01AC04

治疗领域:Peripheral Vascular Diseases;Stroke;Myocardial Infarction

药理分类:Antithrombotic agents

修订号:29 · 最新影响 PI 的程序:N/0000316467

适应症(原文):Secondary prevention of atherothrombotic events Clopidogrel is indicated in: Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. Adult patients suffering from acute coronary syndrome. Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA). ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. In patients with moderate to high-risk Transient Ischaemic Attack (TIA) or minor Ischaemic Stroke (IS) Clopidogrel in combination with ASA is indicated in: Adult patients with moderate to high-risk TIA (ABCD2 score ?4) or minor IS (NIHSS ?3) within 24 hours of either the TIA or IS event. Prevention of atherothrombotic and thromboembolic events in atrial fibrillation: In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke. For further information please refer to section 5.1.

关键日期时间轴

来自 EMA medicines JSON 日期字段;缺失字段不展示,不补推结论。

  1. 2025-12-12 · 欧委会决定

  2. 2009-10-16 · 获批上市许可

  3. 2009-07-23 · CHMP 意见通过

说明书、EPAR 与其他文件

仅展示 EMA 官方 document_url;本站不下载或镜像 PDF。

EPAR / 审评资料 4产品信息 2其他 0

EPAR / 审评资料

  • Clopidogrel Viatris : EPAR - Procedural steps taken and scientific information after authorisation

    procedural-steps-after · 2025-12-12

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  • Clopidogrel Viatris : EPAR - Procedural steps taken and scientific information after authorisation (archive)

    procedural-steps-after · 2025-12-12

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  • Clopidogrel Mylan Pharma : EPAR - Public assessment report

    assessment-report · 2009-11-09

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  • Clopidogrel Viatris : EPAR - Medicine overview

    overview · 2010-03-15 · EMA/565316/2021

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产品信息

  • Clopidogrel Viatris : EPAR - Product information

    product-information · 2025-12-12

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  • Clopidogrel Viatris : EPAR - All Authorised presentations

    all-authorised-presentations · 2009-11-09

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数据来自 EMA 官方 JSON;最终以 EMA / 欧委会文件为准。本页不自动给出安全或非安全结论。