欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Grepid
适用类别Human
治疗领域Peripheral Vascular Diseases;Stroke;Myocardial Infarction
通用名/非专利名称clopidogrel
活性成分clopidogrel (as besilate)
产品号EMEA/H/C/001059
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Pharmathen S.A.
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2025/06/20
修订号29
治疗适应症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 seven days until less than six 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 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2018/05/31
最后更新日期2025/06/23
产品说明书https://www.ema.europa.eu/en/documents/product-information/grepid-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/grepid
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