| 商品名称 | Angiox |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Acute Coronary Syndrome |
| 通用名/非专利名称 | bivalirudin |
| 活性成分 | Bivalirudin |
| 产品号 | EMEA/H/C/000562 |
| 患者安全信息 | No |
| 许可状态 | Withdrawn |
| ATC编码 | B01AE06 |
| 是否额外监管 | No |
| 是否仿制药或hybrid药物 | No |
| 是否生物类似药 | No |
| 是否附条件批准 | No |
| 是否特殊情形 | No |
| 是否加速审评 | No |
| 是否罕用药 | No |
| 上市许可日期 | 2004/09/20 |
| 上市许可开发者/申请人/持有人 | The Medicines Company UK Ltd |
| 人用药物治疗学分组 | Antithrombotic agents |
| 兽用药物治疗学分组 | |
| 欧盟委员会决定日期 | 2016/10/25 |
| 修订号 | 22 |
| 治疗适应症 | Angiox is indicated as an anticoagulant in adult patients undergoing percutaneous coronary intervention (PCI), including patients with ST-segment-elevation myocardial infarction (STEMI) undergoing primary PCI. Angiox is also indicated for the treatment of adult patients with unstable angina / non-ST-segment-elevation myocardial infarction (UA / NSTEMI) planned for urgent or early intervention. Angiox should be administered with aspirin and clopidogrel. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2016/10/25 |
| 最后更新日期 | 2018/09/14 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/angiox-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/angiox |