Triumeq
abacavir sulfate / dolutegravir sodium / lamivudine
Table of contents
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.
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List item
Triumeq : EPAR - Summary for the public (PDF/71.68 KB)
First published: 15/10/2014
Last updated: 15/10/2014
EMA/546473/2014 -
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Triumeq : EPAR - Risk-management-plan summary (PDF/176.99 KB)
First published: 15/10/2014
Last updated: 11/10/2019
Authorisation details
Product details | |
---|---|
Name |
Triumeq
|
Agency product number |
EMEA/H/C/002754
|
Active substance |
|
International non-proprietary name (INN) or common name |
abacavir sulfate / dolutegravir sodium / lamivudine
|
Therapeutic area (MeSH) |
HIV Infections
|
Anatomical therapeutic chemical (ATC) code |
J05AR13
|
Publication details | |
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Marketing-authorisation holder |
ViiV Healthcare BV
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Revision |
14
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Date of issue of marketing authorisation valid throughout the European Union |
31/08/2014
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Contact address |
Product information
20/06/2019 Triumeq - EMEA/H/C/002754 - R/0063
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.