| 商品名称 | Talzenna |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Breast Neoplasms |
| 通用名/非专利名称 | talazoparib |
| 活性成分 | talazoparib |
| 产品号 | EMEA/H/C/004674 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L01XK04 |
| 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 |
| 上市许可日期 | 2019/06/20 |
| 上市许可开发者/申请人/持有人 | Pfizer Europe MA EEIG |
| 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 | 2019/04/26 |
| 欧盟委员会决定日期 | 2025/06/19 |
| 修订号 | 11 |
| 治疗适应症 | Treatment with Talzenna should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. Patient selection Breast cancer: Patients should be selected for the treatment of breast cancer with Talzenna based on the presence of deleterious or suspected deleterious germline BRCA mutations determined by an experienced laboratory using a validated test method. Genetic counselling for patients with BRCA mutations should be performed according to local regulations, as applicable. Prostate cancer: There is no requirement for tumour mutation testing for selection of patients with mCRPC for treatment with Talzenna. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2019/07/08 |
| 最后更新日期 | 2025/08/29 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/talzenna-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/talzenna |