| 商品名称 | Stivarga |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Colorectal Neoplasms |
| 通用名/非专利名称 | regorafenib |
| 活性成分 | regorafenib |
| 产品号 | EMEA/H/C/002573 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L01EX05 |
| 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 | 2013/08/26 |
| 上市许可开发者/申请人/持有人 | Bayer Pharma AG |
| 人用药物治疗学分组 | Antineoplastic agents;Protein kinase inhibitors |
| 兽用药物治疗学分组 | |
| 欧盟委员会决定日期 | 2025/07/01 |
| 修订号 | 23 |
| 治疗适应症 | Stivarga is indicated as monotherapy for the treatment of adult patients with: metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies - these include fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy; unresectable or metastatic gastrointestinal stromal tumors (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib; hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/06/25 |
| 最后更新日期 | 2025/07/02 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/stivarga-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/stivarga |