| 商品名称 | Eptifibatide Accord |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Myocardial Infarction |
| 通用名/非专利名称 | eptifibatide |
| 活性成分 | eptifibatide |
| 产品号 | EMEA/H/C/004104 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | B01AC16 |
| 是否额外监管 | No |
| 是否仿制药或hybrid药物 | Yes |
| 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 | 2016/01/11 |
| 上市许可开发者/申请人/持有人 | Accord Healthcare S.L.U. |
| 人用药物治疗学分组 | Antithrombotic agents |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2015/11/19 |
| 欧盟委员会决定日期 | 2025/05/02 |
| 修订号 | 8 |
| 治疗适应症 | Eptifibatide Accord is intended for use with acetylsalicylic acid and unfractionated heparin. Eptifibatide Accord is indicated for the prevention of early myocardial infarction in adults presenting with unstable angina or non-Q-wave myocardial infarction, with the last episode of chest pain occurring within 24 hours and with electrocardiogram (ECG) changes and/or elevated cardiac enzymes. Patients most likely to benefit from Eptifibatide Accord treatment are those at high risk of developing myocardial infarction within the first 3-4 days after onset of acute angina symptoms including for instance those that are likely to undergo an early PTCA (Percutaneous Transluminal Coronary Angioplasty). |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2016/01/11 |
| 最后更新日期 | 2025/05/02 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/eptifibatide-accord-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/eptifibatide-accord |