| 商品名称 | Trodelvy |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Breast Neoplasms;Triple Negative Breast Neoplasms |
| 通用名/非专利名称 | sacituzumab govitecan |
| 活性成分 | sacituzumab govitecan |
| 产品号 | EMEA/H/C/005182 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L01FX06 |
| 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 | 2021/11/22 |
| 上市许可开发者/申请人/持有人 | Gilead Sciences Ireland UC |
| 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 | 2021/09/16 |
| 欧盟委员会决定日期 | 2025/06/05 |
| 修订号 | 5 |
| 治疗适应症 | Trodelvy as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, including at least one of them for advanced disease. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2021/11/24 |
| 最后更新日期 | 2025/08/21 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/trodelvy-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/trodelvy |