Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 06 September 2018

Indication(s)

Hepsera is indicated for the treatment of chronic hepatitis B in adults with:
- compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and fibrosis. Initiation of Hepsera treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate.
- decompensated liver disease in combination with a second agent without cross-resistance to Hepsera.

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Category Value
Agency product number EMEA/H/C/000485
Orphan designation No
Date First Approved 06-03-2003
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Gilead Sciences Ireland UC