欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Clopidogrel ratiopharm GmbH
适用类别Human
治疗领域Peripheral Vascular Diseases;Acute Coronary Syndrome;Myocardial Infarction;Stroke
通用名/非专利名称clopidogrel
活性成分clopidogrel
产品号EMEA/H/C/001165
患者安全信息No
许可状态Withdrawn
ATC编码B01AC04
是否额外监管No
是否仿制药或hybrid药物Yes
是否生物类似药No
是否附条件批准No
是否特殊情形No
是否加速审评No
是否罕用药No
上市许可日期2009/07/28
上市许可开发者/申请人/持有人Archie Samiel s.r.o.
人用药物治疗学分组Antithrombotic agents
兽用药物治疗学分组
欧盟委员会决定日期2019/08/22
修订号12
治疗适应症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; 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.
适用物种
兽用药物ATC编码
首次发布日期2018/04/13
最后更新日期2021/01/25
产品说明书https://www.ema.europa.eu/en/documents/product-information/clopidogrel-ratiopharm-gmbh-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/clopidogrel-ratiopharm-gmbh
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