This is a summary of the European public assessment report (EPAR) for Baraclude. 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 Baraclude.
Baraclude : EPAR - Summary for the public (PDF/72.33 KB)
First published: 21/05/2007
Last updated: 29/09/2014
Baraclude : EPAR - Risk-management-plan summary (PDF/232.42 KB)
First published: 28/05/2020
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Hepatitis B, Chronic
|Anatomical therapeutic chemical (ATC) code||
Bristol-Myers Squibb Pharma EEIG
|Date of issue of marketing authorisation valid throughout the European Union||
17/04/2020 Baraclude - EMEA/H/C/000623 - II/0064
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Antivirals for systemic use
Baraclude 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.