Data from EMA (European Medicines Agency) - Curated by Marshall Pearce - Last updated 12 October 2017

Indication(s)

Entecavir Mylan 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, see sections 4.2, 4.4 and 5.1.

Entecavir Mylan 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, see sections 4.2, 4.4, and 5.1.

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Category Value
Agency product number EMEA/H/C/004377
Orphan designation No
Date First Approved 18-09-2017
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Mylan S.A.S