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 29/10/2018

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
23
Date of issue of marketing authorisation valid throughout the European Union
26/06/2006
Contact address
Uxbridge Business Park
Sanderson Road
Uxbridge UB8 1DH
United Kingdom

Product information

13/09/2018 Baraclude - EMEA/H/C/000623 - II/0059

Contents

  • 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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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