欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Clopidogrel/Acetylsalicylic acid Teva
适用类别Human
治疗领域Acute Coronary Syndrome;Myocardial Infarction
通用名/非专利名称clopidogrel;acetylsalicylic acid
活性成分clopidogrel;acetylsalicylic acid
产品号EMEA/H/C/002272
患者安全信息No
许可状态Withdrawn
ATC编码B01AC30
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2014/09/01
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combinations
兽用药物治疗学分组
审评意见日期2014/06/26
欧盟委员会决定日期2016/06/03
修订号1
治疗适应症Clopidogrel/Acetylsalicylic acid Teva is indicated for the prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). Clopidogrel/Acetylsalicylic acid Teva is a fixed?dose combination medicinal product for continuation of therapy in: 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 ST segment elevation acute myocardial infarction 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2016/06/03
最后更新日期2017/04/28
产品说明书
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/clopidogrel-acetylsalicylic-acid-teva
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