| 商品名称 | Pradaxa |
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| 适用类别 | Human |
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| 治疗领域 | Arthroplasty, Replacement;Venous Thromboembolism |
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| 通用名/非专利名称 | dabigatran etexilate |
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| 活性成分 | dabigatran etexilate mesilate |
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| 产品号 | EMEA/H/C/000829 |
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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 | B01AE07 |
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| 是否额外监管 | No |
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| 是否仿制药或hybrid药物 | 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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| 上市许可日期 | 2008/03/17 |
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| 上市许可开发者/申请人/持有人 | Boehringer Ingelheim International GmbH |
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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 | 2025/11/24 |
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| 修订号 | 45 |
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| 治疗适应症 | Pradaxa 75 mg Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery. Pradaxa 110 mg Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery. Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischemic attack (TIA); age ≥ 75 years; heart failure (NYHA Class ≥ II); diabetes mellitus; hypertension. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. Pradaxa 150 mg Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischemic attack (TIA); age ≥ 75 years; heart failure (NYHA Class ≥ II); diabetes mellitus; hypertension. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. |
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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 | 2018/06/07 |
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| 最后更新日期 | 2025/12/16 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/pradaxa-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/pradaxa |
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