法规知识库 · EMA 集中审评
Zyllt
clopidogrel (as hydrogen sulfate) · EMEA/H/C/001058 · 已授权
获批上市许可
2009-09-28
欧委会决定日
2025-05-13
持有人 / 申请人
KRKA tovarna zdravil d.d. Novo mesto
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:B01AC04
治疗领域:Peripheral Vascular Diseases;Stroke;Acute Coronary Syndrome;Myocardial Infarction
药理分类:Antithrombotic agents
修订号:18 · 最新影响 PI 的程序:N/0000268052
适应症(原文):Prevention Secondary prevention of atherothrombotic events Clopidogrel 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 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
2009-09-28 · 获批上市许可
说明书、EPAR 与其他文件
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EPAR / 审评资料
- 打开官方文件 ↗
Zyllt : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-05-14
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Zyllt : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-05-14
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Zyllt : EPAR - Summary for the public
overview · 2009-10-14
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Zyllt : EPAR - Public assessment report
assessment-report · 2009-10-14
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。