| Product No | EMEA/H/C/004919 |
|---|---|
| Brand Name | Vitrakvi |
| Nonproprietary Name | larotrectinib |
| API | larotrectinib sulfate |
| ATC Code | L01XE53 |
| Indications | 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, andwho have no satisfactory treatment options. |
| Orphan Drug | no |
| Generics | no |
| Marketing Authorization Holder | Bayer AG |
| Status | Authorised(授权) |
| Authorization Date | 2019-09-19 |
| Version | 8 |
| Condition Approval | yes |
| 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