法规知识库 · EMA 集中审评
Clopidogrel Krka d.d. (previously Zopya)
clopidogrel (as hydrochloride) · EMEA/H/C/001137 · 已授权
获批上市许可
2009-09-20
欧委会决定日
2025-05-13
持有人 / 申请人
Norpharm Regulatory Services Ltd
终止日期字段
无
从产品到官方文件
文件记录
7
官方索引 7
EPAR / 审评
4
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC:B01AC03
治疗领域:Peripheral Vascular Diseases;Stroke;Myocardial Infarction
药理分类:—
修订号:16 · 最新影响 PI 的程序:N/0000267861
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 35days), ischaemic stroke (from 7days until less than 6months) 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 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.
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。
2025-05-13 · 欧委会决定
2009-09-20 · 获批上市许可
说明书、EPAR 与其他文件
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EPAR / 审评资料
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Clopidogrel Krka d.d.: EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-05-13
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Clopidogrel Krka d.d.: EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-05-13
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Clopidogrel Krka d.d. : EPAR - Summary for the public
overview · 2012-01-23
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Zopya : EPAR - Public assessment report
assessment-report · 2009-10-14
产品信息
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Clopidogrel Krka d.d. : EPAR - Product information - tracked changes
product-information-tracked-changes · 2025-05-13
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Clopidogrel Krka d.d. : EPAR - Product Information
product-information · 2025-05-13
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Clopidogrel Krka d.d. : EPAR - All Authorised presentations
all-authorised-presentations · 2012-01-23
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。