Basic Information
Entecavir Viatris (previously Entecavir Mylan)
Regulatory Information
EMEA/H/C/004377
September 18, 2017
May 18, 2017
9
March 10, 2025
Company Information
Ireland
Damastown Industrial Park Mulhuddart Dublin 15
VIATRIS PHARMA LIMITED
Drug Classification
Active Substances Detail
entecavir monohydrate
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic 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.
Overview Summary
This is a summary of the European public assessment report (EPAR) for Entecavir Viatris (previously Entecavir Mylan). It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Entecavir Viatris. For practical information about using Entecavir Viatris, patients should read the package leaflet or contact their doctor or pharmacist.