| 商品名称 | Pomalidomide Teva |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Multiple Myeloma |
| 通用名/非专利名称 | pomalidomide |
| 活性成分 | Pomalidomide |
| 产品号 | EMEA/H/C/006302 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L04AX06 |
| 是否额外监管 | Yes |
| 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 | 2024/11/14 |
| 上市许可开发者/申请人/持有人 | Teva GmbH |
| 人用药物治疗学分组 | Immunosuppressants |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2024/09/19 |
| 欧盟委员会决定日期 | 2024/11/14 |
| 修订号 | |
| 治疗适应症 | Pomalidomide Teva in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide. Pomalidomide Teva in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2024/09/20 |
| 最后更新日期 | 2024/11/28 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/pomalidomide-teva-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/pomalidomide-teva |