Baraclude

RSS

entecavir

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 22/05/2019

Authorisation details

Product details
Name
Baraclude
Agency product number
EMEA/H/C/000623
Active substance
Entecavir
International non-proprietary name (INN) or common name
entecavir
Therapeutic area (MeSH)
Hepatitis B, Chronic
Anatomical therapeutic chemical (ATC) code
J05AF10
Publication details
Marketing-authorisation holder
Bristol-Myers Squibb Pharma EEIG
Revision
24
Date of issue of marketing authorisation valid throughout the European Union
26/06/2006
Contact address

Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland

Product information

13/05/2019 Baraclude - EMEA/H/C/000623 - N/0062

Contents

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Pharmacotherapeutic group

Antivirals for systemic use

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.

Assessment history

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