| 商品名称 | Vitrakvi |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Abdominal Neoplasms |
| 通用名/非专利名称 | larotrectinib |
| 活性成分 | larotrectinib sulfate |
| 产品号 | EMEA/H/C/004919 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L01XE53 |
| 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 | Yes |
| 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 | 2019/09/19 |
| 上市许可开发者/申请人/持有人 | Bayer AG |
| 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 | 2019/07/25 |
| 欧盟委员会决定日期 | 2025/08/04 |
| 修订号 | 14 |
| 治疗适应症 | Vitrakvi as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory treatment options. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2019/10/24 |
| 最后更新日期 | 2025/08/04 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/vitrakvi-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/vitrakvi |