| 商品名称 | Clopidogrel / Acetylsalicylic acid Viatris (previously Clopidogrel / Acetylsalicylic acid Mylan) |
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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 | acetylsalicylic acid;clopidogrel hydrogen sulfate |
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| 产品号 | EMEA/H/C/004996 |
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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 | B01AC30 |
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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 | 2020/01/09 |
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| 上市许可开发者/申请人/持有人 | Mylan Pharmaceuticals 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 | 2019/11/14 |
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| 欧盟委员会决定日期 | 2025/05/02 |
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| 修订号 | 9 |
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| 治疗适应症 | Clopidogrel/Acetylsalicylic acid Viatris is indicated for the secondary prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). Clopidogrel/Acetylsalicylic acid Viatris 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 |
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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 | 2020/01/24 |
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| 最后更新日期 | 2025/05/05 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/clopidogrel-acetylsalicylic-acid-viatris-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-acetylsalicylic-acid-viatris |
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