lamivudine / raltegravir potassium

This medicine is now withdrawn from use in the European Union.


The marketing authorisation for Dutrebis has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 27/04/2017

Authorisation details

Product details
Agency product number
Active substance
  • lamivudine
  • raltegravir potassium
International non-proprietary name (INN) or common name
  • lamivudine
  • raltegravir potassium
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Merck Sharp Dohme Limited
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Hertford Road
EN11 9BU Hoddesdon
United Kingdom

Product information

26/03/2015 Dutrebis - EMEA/H/C/003823 - -

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Product information documents contain:

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

  • Antivirals for systemic use

  • 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).

Assessment history

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