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Zyllt

clopidogrel (as hydrogen sulfate) · EMEA/H/C/001058 · 已授权

仿制药

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。

  1. 2025-05-13 · 欧委会决定

  2. 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 4产品信息 3其他 0

EPAR / 审评资料

  • 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

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产品信息

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。