| 商品名称 | Truqap |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Breast Neoplasms |
| 通用名/非专利名称 | capivasertib |
| 活性成分 | capivasertib |
| 产品号 | EMEA/H/C/006017 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L01EX27 |
| 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 | 2024/06/17 |
| 上市许可开发者/申请人/持有人 | AstraZeneca AB |
| 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 | 2024/04/25 |
| 欧盟委员会决定日期 | 2025/09/18 |
| 修订号 | 3 |
| 治疗适应症 | Truqap is indicated in combination with fulvestrant for the treatment of adult patients with oestrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following recurrence or progression on or after an endocrine-based regimen. In pre- or perimenopausal women, Truqap plus fulvestrant should be combined with a luteinising hormone releasing hormone (LHRH) agonist. For men, administration of LHRH agonist according to current clinical practice standards should be considered. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2024/07/11 |
| 最后更新日期 | 2025/11/04 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/truqap-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/truqap |