Triumeq

RSS

abacavir sulfate / dolutegravir sodium / 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 Triumeq. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Triumeq.

For practical information about using Triumeq, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 17/09/2018

Authorisation details

Product details
Name
Triumeq
Agency product number
EMEA/H/C/002754
Active substance
  • abacavir sulfate
  • dolutegravir sodium
  • lamivudine
International non-proprietary name (INN) or common name
abacavir sulfate / dolutegravir sodium / lamivudine
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AR13
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
ViiV Healthcare UK Limited
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
31/08/2014
Contact address
980 Great West Road
Brentford TW8 9GS
United Kingdom

Product information

12/07/2018 Triumeq - EMEA/H/C/002754 - II/0053

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

Triumeq is indicated for the treatment of Human Immunodeficiency Virus (HIV) infected adults and adolescents above 12 years of age weighing at least 40 kg.

Before initiating treatment with abacavir-containing products, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin. Abacavir should not be used in patients known to carry the HLA-B*5701 allele.

Assessment history

How useful was this page?

Add your rating