Baraclude
entecavir
Table of contents
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.
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List item
Baraclude : EPAR - Summary for the public (PDF/72.33 KB)
First published: 21/05/2007
Last updated: 29/09/2014 -
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List item
Baraclude : EPAR - Risk-management-plan summary (PDF/232.42 KB)
First published: 28/05/2020
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 |
27
|
Date of issue of marketing authorisation valid throughout the European Union |
26/06/2006
|
Contact address |
Plaza 254 |
Product information
31/01/2022 Baraclude - EMEA/H/C/000623 - IAIN/0073
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.