Zeffix

RSS

lamivudine

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

Overview

This is a summary of the European public assessment report (EPAR) for Zeffix. 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 Zeffix.

This EPAR was last updated on 23/02/2018

Authorisation details

Product details
Name
Zeffix
Agency product number
EMEA/H/C/000242
Active substance
lamivudine
International non-proprietary name (INN) or common name
lamivudine
Therapeutic area (MeSH)
Hepatitis B, Chronic
Anatomical therapeutic chemical (ATC) code
J05AF05
Publication details
Marketing-authorisation holder
Glaxo Group Ltd
Revision
21
Date of issue of marketing authorisation valid throughout the European Union
28/07/1999
Contact address
980 Great West Road
Brentford
Middlesex TW8 9GS
United Kingdom

Product information

25/01/2018 Zeffix - EMEA/H/C/000242 - II/0069

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

Zeffix is indicated for the treatment of chronic hepatitis B in adults with:

  • compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and / or fibrosis. Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate;
  • decompensated liver disease in combination with a second agent without cross-resistance to lamivudine.

Assessment history

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