<p>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.</p><p>For practical information about using Entecavir Viatris, patients should read the package leaflet or contact their doctor or pharmacist.</p>
Therapeutic Indication
<div class="subsection mt-3-5"> <h3>Therapeutic indication</h3><p>Entecavir Viatris is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with:<br> - 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.<br> - decompensated liver disease.<br> <br> 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.<br> <br> 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.</p> </div>
Therapeutic Area (MeSH)
ATC Code
J05AF10
ATC Item
N/A
Pharmacotherapeutic Group
Antivirals for systemic use
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| entecavir monohydrate | N/A | entecavir monohydrate |
EMA Name
Entecavir Viatris (previously Entecavir Mylan)
Medicine Name
Entecavir Viatris (previously Entecavir Mylan)
Aliases
N/ANo risk management plan link.
