Entecavir Viatris (previously Entecavir Mylan) (entecavir)
- Region
- 🇪🇺 EU
- Active substance
- entecavir
- Company
- Viatris Limited
- Status
- Authorised
- Therapeutic area
- Hepatitis B
- CHMP opinion
- Thu 18 May 2017
- EU approval
- Mon 18 Sep 2017
- Designations
- Generic
- Application
- EMEA/H/C/004377
- ATC
- J05AF10
- Official record
- www.ema.europa.eu
Indication
Entecavir Viatris 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 Viatris is also indicated for the treatment of chronic HBV infection in nucleoside naive paediatric patients from 2 to <18 years of age with compensated liver disease who have evidence of active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis. With respect to the decision to initiate treatment in paediatric patients.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Baraclude Authorised · Bristol-Myers Squibb Pharma EEIG
- 🇪🇺 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.