Dutrebis
lamivudine / raltegravir potassium
Table of contents
Overview
The marketing authorisation for Dutrebis has been withdrawn at the request of the marketing authorisation holder.
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List item
Dutrebis : EPAR - Summary for the public (PDF/545.33 KB)
First published: 21/04/2015
Last updated: 27/04/2017 -
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List item
Dutrebis : EPAR - Risk-management-plan summary (PDF/583.5 KB)
First published: 21/04/2015
Last updated: 27/04/2017
Authorisation details
| Product details | |
|---|---|
| Name |
Dutrebis
|
| Agency product number |
EMEA/H/C/003823
|
| Active substance |
|
| International non-proprietary name (INN) or common name |
lamivudine / raltegravir potassium
|
| Therapeutic area (MeSH) |
HIV Infections
|
| Anatomical therapeutic chemical (ATC) code |
J05AR16
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Merck Sharp Dohme Limited
|
| Revision |
0
|
| Date of issue of marketing authorisation valid throughout the European Union |
26/03/2015
|
| Contact address | |
Product information
26/03/2015 Dutrebis - EMEA/H/C/003823 - -
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
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Antivirals for treatment of HIV infections
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combinations
Therapeutic indication
Dutrebis is indicated in combination with other anti‑retroviral medicinal products for the treatment of human immunodeficiency virus (HIV‑1) infection in adults, adolescents, and children from the age of 6 years and weighing at least 30 kg without present or past evidence of viral resistance to antiviral agents of the InSTI (Integrase Strand Transfer Inhibitor) and NRTI (Nucleoside Reverse Transcriptase Inhibitor) classes (see sections 4.2, 4.4 and 5.1).