Epivir

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 Epivir. 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 Epivir.

This EPAR was last updated on 07/03/2018

Authorisation details

Product details
Name
Epivir
Agency product number
EMEA/H/C/000107
Active substance
lamivudine
International non-proprietary name (INN) or common name
lamivudine
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AF05
Publication details
Marketing-authorisation holder
ViiV Healthcare UK Limited 
Revision
39
Date of issue of marketing authorisation valid throughout the European Union
07/08/1996
Contact address
ViiV Healthcare UK Limited
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom

Product information

04/03/2018 Epivir - EMEA/H/C/000107 - II/0104

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

Epivir is indicated as part of antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV)-infected adults and children.

Assessment history

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