| 商品名称 | Orserdu |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Breast Neoplasms |
| 通用名/非专利名称 | elacestrant |
| 活性成分 | elacestrant |
| 产品号 | EMEA/H/C/005898 |
| 患者安全信息 | no |
| 授权状态 | Authorised |
| ATC编码 | L02BA |
| 是否额外监管 | yes |
| 是否仿制药 | 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 |
| 批准上市日期 | 2023/09/15 |
| 上市许可持有人/公司名称 | Stemline Therapeutics B.V. |
| 人用药物治疗分组 | Endocrine therapy |
| 审评意见发布日期 | 2023/07/20 |
| 修订号 | |
| 适应症 | Orserdu monotherapy is indicated for the treatment of postmenopausal women, and men, with estrogen receptor (ER) positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor. |
| 首次发布日期 | 2023/07/18 |
| 修订日期 | 2023/11/27 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/orserdu-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/orserdu |