| 商品名称 | Etcamah |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Breast Neoplasms |
| 通用名/非专利名称 | camizestrant |
| 活性成分 | camizestrant |
| 产品号 | EMEA/H/C/006494 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L02BA05 |
| 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 | 2026/07/20 |
| 上市许可开发者/申请人/持有人 | AstraZeneca AB |
| 人用药物治疗学分组 | Endocrine therapy |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2026/05/21 |
| 修订号 | |
| 治疗适应症 | Etcamah in combination with a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) is indicated for the treatment of adult patients with ER-positive, HER2-negative, locally advanced or metastatic breast cancer upon detection of ESR1‑mutation and without disease progression during first-line endocrine therapy in combination with a CDK4/6 inhibitor (for biomarker based patient-selection, see section 4.2 and 5.1). |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2026/05/22 |
| 最后更新日期 | 2026/07/21 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/etcamah-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/etcamah |