| 商品名称 | Cevenfacta |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Hemophilia A;Hemophilia B |
| 通用名/非专利名称 | eptacog beta (activated) |
| 活性成分 | Eptacog beta (activated) |
| 产品号 | EMEA/H/C/005655 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | B02BD08 |
| 是否额外监管 | Yes |
| 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 | 2022/07/15 |
| 上市许可开发者/申请人/持有人 | Laboratoire Francais du Fractionnement et des Biotechnologies |
| 人用药物治疗学分组 | Antihemorrhagics |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2022/05/19 |
| 欧盟委员会决定日期 | 2022/05/19 |
| 修订号 | |
| 治疗适应症 | CEVENFACTA is indicated in adults and adolescents (12 years of age and older) for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups: in patients with congenital haemophilia with high-responding inhibitors to coagulation factors VIII or IX (i.e. ?5 Bethesda Units (BU)); in patients with congenital haemophilia with low titre inhibitors (BU <5), but expected to have a high anamnestic response to factor VIII or factor IX administration or expected to be refractory to increased dosing of FVIII or FIX. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2022/05/17 |
| 最后更新日期 | 2022/11/29 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/cevenfacta-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/cevenfacta |