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法规知识库 · EMA 集中审评

Clopidogrel Teva (hydrogen sulphate)

clopidogrel (as hydrogen sulfate) · EMEA/H/C/001053 · 已授权

仿制药

获批上市许可

2009-07-27

欧委会决定日

2024-02-08

持有人 / 申请人

Teva Pharma B.V.

终止日期字段

无

从产品到官方文件

文件记录

5

官方索引 5

EPAR / 审评

3

assessment / overview 等

产品信息

2

PI / presentations

其他

0

RMP / PIP 等

ATC:B01AC04

治疗领域:Acute Coronary Syndrome;Peripheral Vascular Diseases;Myocardial Infarction;Stroke

药理分类:Antithrombotic agents

修订号:19 · 最新影响 PI 的程序:IB/0059/G

适应症(原文):Secondary prevention of atherothrombotic eventsClopidogrel is indicated in: Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic 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. Prevention of atherothrombotic and thromboembolic events in atrial fibrillationIn 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.

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. 2024-02-08 · 欧委会决定

  2. 2009-07-27 · 获批上市许可

  3. 2009-05-29 · 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 3产品信息 2其他 0

EPAR / 审评资料

  • Clopidogrel Teva (hydrogen sulphate) : EPAR - Procedural steps taken and scientific information after authorisation

    procedural-steps-after · 2024-02-29

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  • Clopidogrel Teva (hydrogen sulphate) : EPAR - Public assessment report

    assessment-report · 2010-06-14

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  • Clopidogrel Teva (hydrogen sulphate) : EPAR - Summary for the public

    overview · 2009-08-12

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产品信息

  • Clopidogrel Teva (hydrogen sulphate) : EPAR - Product Information

    product-information · 2024-02-29

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  • Clopidogrel Teva (hydrogen sulphate) : EPAR - All Authorised presentations

    all-authorised-presentations · 2013-11-27

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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。