| 商品名称 | Nexpovio |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Multiple Myeloma |
| 通用名/非专利名称 | selinexor |
| 活性成分 | selinexor |
| 产品号 | EMEA/H/C/005127 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L01XX66 |
| 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 | 2021/03/26 |
| 上市许可开发者/申请人/持有人 | Stemline Therapeutics B.V. |
| 人用药物治疗学分组 | Antineoplastic agents |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2021/01/28 |
| 欧盟委员会决定日期 | 2023/08/14 |
| 修订号 | 8 |
| 治疗适应症 | NEXPOVIO is indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, and who 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 | 2021/05/27 |
| 最后更新日期 | 2023/08/17 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/nexpovio-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/nexpovio |