| Product No | EMEA/H/C/000623 |
|---|---|
| Brand Name | Baraclude |
| Nonproprietary Name | entecavir |
| API | Entecavir |
| ATC Code | J05AF10 |
| Indications | Baraclude 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. |
| Orphan Drug | no |
| Generics | no |
| Marketing Authorization Holder | Bristol-Myers Squibb Pharma EEIG |
| Status | Authorised(授权) |
| Authorization Date | 2006-06-26 |
| Version | 27 |
| 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