| Product No | EMEA/H/C/004377 |
|---|---|
| Brand Name | Entecavir Mylan |
| Nonproprietary Name | entecavir |
| API | entecavir monohydrate |
| ATC Code | J05AF10 |
| Indications | Entecavir Mylan is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with:, compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis., decompensated liver disease.,For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B.,Entecavir Mylan is also indicated for the treatment of chronic HBV infection in nucleoside naive paediatric patients from 2 to |
| Orphan Drug | no |
| Generics | yes |
| Marketing Authorization Holder | Mylan Pharmaceuticals Limited |
| Status | Authorised(授权) |
| Authorization Date | 2017-09-18 |
| Version | 5 |
| 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