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The marketing authorisation for Dutrebis has been withdrawn at the request of the marketing authorisation holder.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 |
|
| 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 |
Hertford Road
EN11 9BU Hoddesdon United Kingdom |
Product information
26/03/2015 Dutrebis - EMEA/H/C/003823 - -
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
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Antivirals for systemic use
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Antivirals for treatment of HIV infections, 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).