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.
Therapeutic Indication
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.
Therapeutic Area (MeSH)
ATC Code
J05AF10
ATC Item
N/A
Pharmacotherapeutic Group
Antivirals for systemic use
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| Entecavir | N/A | Entecavir |
EMA Name
Baraclude
Medicine Name
Baraclude
Aliases
N/ANo risk management plan link.
