| 商品名称 | Aumseqa |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Carcinoma, Non-Small-Cell Lung |
| 通用名/非专利名称 | Aumolertinib |
| 活性成分 | Aumolertinib mesilate |
| 产品号 | EMEA/H/C/006069 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L01EB |
| 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 | 2026/02/12 |
| 上市许可开发者/申请人/持有人 | SFL Pharmaceuticals Deutschland GmbH |
| 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 | 2025/12/11 |
| 修订号 | |
| 治疗适应症 | Aumseqa as monotherapy is indicated for:- the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC)whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations (forbiomarker-based patient selection, see section 4.2).- the treatment of adult patients with advanced EGFR T790M mutation-positive NSCLC (forbiomarker-based patient selection, see section 4.2) |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2025/12/12 |
| 最后更新日期 | 2026/02/27 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/aumseqa-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/aumseqa |