欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Zyllt
适用类别Human
治疗领域Peripheral Vascular Diseases;Stroke;Acute Coronary Syndrome;Myocardial Infarction
通用名/非专利名称clopidogrel
活性成分clopidogrel (as hydrogen sulfate)
产品号EMEA/H/C/001058
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Yes
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2009/09/28
上市许可开发者/申请人/持有人Krka, d.d., Novo mesto
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2025/05/13
修订号18
治疗适应症Prevention 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 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 (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2018/04/24
最后更新日期2025/05/14
产品说明书https://www.ema.europa.eu/en/documents/product-information/zyllt-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/zyllt
©2006-2025 DrugFuture->European Medicines Agency Authorisation of Medicines DataBase