| 商品名称 | Braftovi |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Melanoma;Colorectal Neoplasms |
| 通用名/非专利名称 | encorafenib |
| 活性成分 | Encorafenib |
| 产品号 | EMEA/H/C/004580 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L01EC03 |
| 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 | 2018/09/19 |
| 上市许可开发者/申请人/持有人 | Pierre Fabre Medicament |
| 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 | 2018/07/26 |
| 欧盟委员会决定日期 | 2025/09/18 |
| 修订号 | 17 |
| 治疗适应症 | MelanomaEncorafenib in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.Colorectal cancer (CRC)Encorafenib in combination with cetuximab is indicated for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, who have received prior systemic therapy.Non-small cell lung cancer (NSCLC)Encorafenib in combination with binimetinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/07/27 |
| 最后更新日期 | 2025/11/05 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/braftovi-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/braftovi |