欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Clopidogrel Teva (hydrogen sulphate)
适用类别Human
治疗领域Acute Coronary Syndrome;Peripheral Vascular Diseases;Myocardial Infarction;Stroke
通用名/非专利名称clopidogrel
活性成分clopidogrel (as hydrogen sulfate)
产品号EMEA/H/C/001053
患者安全信息No
许可状态Authorised
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2009/07/27
上市许可开发者/申请人/持有人Teva Pharma B.V.
人用药物治疗学分组Antithrombotic agents
兽用药物治疗学分组
审评意见日期2009/05/29
欧盟委员会决定日期2024/02/08
修订号19
治疗适应症Secondary prevention of atherothrombotic eventsClopidogrel 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 fibrillationIn 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.
适用物种
兽用药物ATC编码
首次发布日期2017/12/04
最后更新日期2024/02/29
产品说明书https://www.ema.europa.eu/en/documents/product-information/clopidogrel-teva-hydrogen-sulphate-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/clopidogrel-teva-hydrogen-sulphate
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