| 商品名称 | Retsevmo |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Carcinoma, Non-Small-Cell Lung;Thyroid Neoplasms |
| 通用名/非专利名称 | selpercatinib |
| 活性成分 | selpercatinib |
| 产品号 | EMEA/H/C/005375 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L01EX22 |
| 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 | Yes |
| 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 | 2021/02/11 |
| 上市许可开发者/申请人/持有人 | Eli Lilly Nederland 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 | 2020/12/10 |
| 欧盟委员会决定日期 | 2025/12/12 |
| 修订号 | 18 |
| 治疗适应症 | Retsevmo as monotherapy is indicated for the treatment of adults with: – advanced RET fusion positive non small cell lung cancer (NSCLC) not previously treated with a RET inhibitor– advanced RET fusion positive solid tumours, when treatment options not targeting RET provide limited clinical benefit, or have been exhausted (see sections 4.4 and 5.1)Retsevmo as monotherapy is indicated for the treatment of adults and adolescents 12 years and older with:– advanced RET fusion positive thyroid cancer who are radioactive iodine-refractory (if radioactive iodine is appropriate)– advanced RET mutant medullary thyroid cancer (MTC) |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2021/04/23 |
| 最后更新日期 | 2025/12/15 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/retsevmo-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/retsevmo |