| 商品名称 | DuoPlavin |
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| 适用类别 | Human |
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| 治疗领域 | Acute Coronary Syndrome; Myocardial Infarction |
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| 通用名/非专利名称 | clopidogrel, acetylsalicylic acid |
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| 活性成分 | clopidogrel, Acetylsalicylic acid |
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| 产品号 | EMEA/H/C/001143 |
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| 患者安全信息 | no |
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| 授权状态 | Authorised |
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| ATC编码 | B01AC30 |
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| 是否额外监管 | no |
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| 是否仿制药 | no |
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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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| 批准上市日期 | 2010/03/14 |
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| 上市许可持有人/公司名称 | Sanofi Winthrop Industrie |
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| 人用药物治疗分组 | Antithrombotic agents |
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| 审评意见发布日期 | 2009/12/17 |
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| 决定日期 | 2023/06/30 |
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| 修订号 | 30 |
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| 适应症 | DuoPlavin is indicated for the secondary prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). DuoPlavin 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 (PCI);ST segment elevation acute myocardial infarction (STEMI) in patients undergoing a stent placement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy.For further information please refer to section 5.1. |
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| 首次发布日期 | 2018/01/18 |
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| 修订日期 | 2023/07/07 |
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| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/duoplavin-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/duoplavin-0 |
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