| 商品名称 | Clopidogrel Taw Pharma (previously Clopidogrel Mylan) |
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| 适用类别 | Human |
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| 治疗领域 | Peripheral Vascular Diseases;Stroke;Myocardial Infarction;Acute Coronary Syndrome |
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| 通用名/非专利名称 | clopidogrel |
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| 活性成分 | clopidogrel hydrochloride |
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| 产品号 | EMEA/H/C/001134 |
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| 患者安全信息 | No |
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| 许可状态 | Authorised |
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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 | 2009/09/21 |
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| 上市许可开发者/申请人/持有人 | Taw Pharma (Ireland) Limited |
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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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| 审评意见日期 | 2009/06/25 |
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| 欧盟委员会决定日期 | 2023/12/18 |
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| 修订号 | 21 |
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| 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 medically treated patients eligible for thrombolytic therapy. In patients with moderate to high-risk Transient Ischaemic Attack (TIA) or minor Ischaemic 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. 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 | 2018/04/13 |
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| 最后更新日期 | 2023/12/19 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/clopidogrel-taw-pharma-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-taw-pharma |
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