| 商品名称 | Pepaxti |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Multiple Myeloma |
| 通用名/非专利名称 | melphalan flufenamide |
| 活性成分 | Melphalan flufenamide hydrochloride |
| 产品号 | EMEA/H/C/005681 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L01AA10 |
| 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 | 2022/08/17 |
| 上市许可开发者/申请人/持有人 | Oncopeptides AB (publ) |
| 人用药物治疗学分组 | Antineoplastic agents |
| 兽用药物治疗学分组 | |
| 欧盟委员会决定日期 | 2025/01/09 |
| 修订号 | 5 |
| 治疗适应症 | Pepaxti is indicated, in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation (see section 4.4). |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2022/06/21 |
| 最后更新日期 | 2025/01/13 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/pepaxti-epar-production-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/pepaxti |