欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Iscover
适用类别Human
治疗领域Stroke;Peripheral Vascular Diseases;Atrial Fibrillation;Myocardial Infarction;Acute Coronary Syndrome
通用名/非专利名称clopidogrel
活性成分clopidogrel
产品号EMEA/H/C/000175
患者安全信息No
许可状态Authorised
ATC编码B01AC04
是否额外监管No
是否仿制药或hybrid药物No
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1998/07/14
上市许可开发者/申请人/持有人Sanofi Winthrop Industrie
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1998/03/25
欧盟委员会决定日期2025/08/26
修订号53
治疗适应症Secondary 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 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 patients undergoing percutaneous coronary intervention (including patients undergoing a stent placement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy. In patients with moderate to high-risk Transient Ischemic Attack (TIA) or minor Ischemic Stroke (IS)Clopidogrel in combination with ASA is indicated in: Adult patients with moderate to high-risk TIA (ABCD2  score ?4) or minor IS (NIHSS  ?3) within 24 hours of either the TIA or IS event. 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 (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2018/01/18
最后更新日期2025/08/26
产品说明书https://www.ema.europa.eu/en/documents/product-information/iscover-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/iscover
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