| 商品名称 | Inluriyo |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Breast Neoplasms |
| 通用名/非专利名称 | imlunestrant |
| 活性成分 | imlunestrant tosilate |
| 产品号 | EMEA/H/C/006184 |
| 患者安全信息 | No |
| 许可状态 | Opinion |
| ATC编码 | L02BA |
| 是否额外监管 | No |
| 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 |
| 上市许可开发者/申请人/持有人 | Eli Lilly Nederland B.V. |
| 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 | 2025/11/13 |
| 修订号 | |
| 治疗适应症 | Inluriyo is indicated as a monotherapy for the treatment of adult patients with estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1-mutation, who have disease progression following prior treatment with an endocrine based regimen (for biomarker-based patient selection, see section 4.2). In pre- or perimenopausal women, or men, Inluriyo should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2025/11/14 |
| 产品说明书 | |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/inluriyo |