Basic Information
Lamivudine Teva
Regulatory Information
EMEA/H/C/001113
October 23, 2009
14
June 7, 2024
Company Information
the netherlands
Swensweg 5 2031GA Haarlem
Teva Pharma B.V.
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Lamivudine Teva 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 (see in section 5.1).
Overview Summary
This is a summary of the European public assessment report (EPAR) for Lamivudine Teva. 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 Lamivudine Teva.