Baraclude (entecavir)
- Region
- 🇪🇺 EU
- Active substance
- entecavir
- Company
- Bristol-Myers Squibb Pharma EEIG
- Status
- Authorised
- Therapeutic area
- Hepatitis B, Chronic
- EU approval
- Mon 26 Jun 2006
- Application
- EMEA/H/C/000623
- ATC
- J05AF10
- Official record
- www.ema.europa.eu
Indication
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Entecavir Viatris (previously Entecavir Mylan) Authorised · Viatris Limited
- 🇪🇺 Entecavir Accord Authorised · Accord Healthcare S.L.U.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.