欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Clopidogrel 1A Pharma
适用类别Human
治疗领域Peripheral Vascular Diseases
通用名/非专利名称clopidogrel
活性成分clopidogrel
产品号EMEA/H/C/001054
患者安全信息No
许可状态Withdrawn
ATC编码B01AC04
是否额外监管Nei
是否仿制药或hybrid药物
是否生物类似药Nei
是否附条件批准Nei
是否特殊情形Nei
是否加速审评Nei
是否罕用药Nei
上市许可日期2009/07/28
上市许可开发者/申请人/持有人Acino Pharma GmbH
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2011/02/01
修订号1
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. For further information please refer to section 5.1.
适用物种
兽用药物ATC编码
首次发布日期2011/02/01
最后更新日期2011/02/28
产品说明书https://www.ema.europa.eu/en/documents/product-information/clopidogrel-1a-pharma-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/clopidogrel-1a-pharma
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