Basic Information
Zeffix
Regulatory Information
EMEA/H/C/000242
July 29, 1999
April 22, 1999
29
March 20, 2024
Company Information
Ireland
12 Riverwalk Citywest Business Campus Dublin 24
GLAXOSMITHKLINE (IRELAND) LIMITED
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Zeffix 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 / or fibrosis. Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate; - decompensated liver disease in combination with a second agent without cross-resistance to lamivudine.
Overview Summary
This is a summary of the European public assessment report (EPAR) for Zeffix. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zeffix.