Product No | EMEA/H/C/004163 |
---|---|
Brand Name | Cabometyx |
Nonproprietary Name | cabozantinib |
API | cabozantinib (s)-malate |
ATC Code | L01EX07 |
Indications | Renal Cell Carcinoma (RCC)Cabometyx is indicated as monotherapy for the treatment of advanced renal cell carcinoma (RCC):in treatment-naïve adults with intermediate or poor risk,in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy.Cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults.Hepatocellular Carcinoma (HCC)Cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib. |
Orphan Drug | no |
Generics | no |
Marketing Authorization Holder | Ipsen Pharma |
Status | Authorised(授权) |
Authorization Date | 2016-09-09 |
Version | 16 |
Condition Approval | no |
Exceptions | no |
Biosimilar | no |
Details | 查看 (公众评估报告、授权细节、产品规格/剂型、标签、历史评估信息) |
Extended Information