| 商品名称 | Clopidogrel Teva Generics B.V. |
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| 适用类别 | Human |
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| 治疗领域 | Peripheral Vascular Diseases;Acute Coronary Syndrome;Myocardial Infarction;Stroke |
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| 通用名/非专利名称 | clopidogrel |
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| 活性成分 | clopidogrel (as hydrochloride) |
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| 产品号 | EMEA/H/C/002254 |
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| 患者安全信息 | No |
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| 许可状态 | Lapsed |
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| ATC编码 | B01AC04 |
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| 是否额外监管 | No |
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| 是否仿制药或hybrid药物 | Yes |
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| 是否生物类似药 | No |
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| 是否附条件批准 | No |
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| 是否特殊情形 | No |
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| 是否加速审评 | No |
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| 是否罕用药 | No |
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| 上市许可日期 | 2010/10/28 |
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| 上市许可开发者/申请人/持有人 | Teva Pharma B.V. |
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| 人用药物治疗学分组 | Antithrombotic agents |
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| 兽用药物治疗学分组 | |
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| 欧盟委员会决定日期 | 2013/11/05 |
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| 修订号 | 3 |
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| 治疗适应症 | Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: 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. 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. For further information please refer to section 5.1. |
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| 适用物种 | |
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| 兽用药物ATC编码 | |
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| 首次发布日期 | 2013/11/05 |
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| 最后更新日期 | 2014/05/12 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/clopidogrel-teva-generics-bv-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/clopidogrel-teva-generics-bv |
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