法规知识库 · EMA 集中审评
Clopidogrel Acino
clopidogrel · EMEA/H/C/001166 · 已撤市
获批上市许可
2009-07-28
欧委会决定日
2016-01-28
持有人 / 申请人
Acino AG
终止日期字段
2017-01-18
从产品到官方文件
文件记录
7
官方索引 7
EPAR / 审评
5
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;Acute Coronary Syndrome;Myocardial Infarction;Stroke
药理分类：Antithrombotic agents
修订号：6 · 最新影响 PI 的程序：IB/0018/G
适应症（原文）：Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: 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 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 Patients suffering from acute coronary syndrome.
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。
2017-01-18 · 上市许可终止（撤市/失效/撤销等）
Withdrawn
2016-01-28 · 欧委会决定
2009-07-28 · 获批上市许可
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
- 打开官方文件 ↗
Clopidogrel Acino : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2016-08-11
- 打开官方文件 ↗
Clopidogrel Acino : EPAR - Summary for the public
overview · 2016-04-15
- 打开官方文件 ↗
Clopidogrel Acino Pharma-H-C-1172-A20-04: EPAR - Assessment Report - Variation
variation-report · 2012-07-26
- 打开官方文件 ↗
Clopidogrel Acino-H-C-1166-A-20-4: EPAR - Assessment Report - Article 20
variation-report · 2011-03-31
- 打开官方文件 ↗
Clopidogrel Acino : EPAR - Public assessment report
assessment-report · 2009-09-09
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。