Dutrebis
Withdrawn
This medicine's authorisation has been withdrawn
lamivudine / raltegravir potassium
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 24 April 2017, the European Commission withdrew the marketing authorisation for Dutrebis (lamivudine / raltegravir) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Merck Sharp & Dohme Limited, which notified the European Commission of its decision to not to market the product in the EU for commercial reasons.
Dutrebis was granted marketing authorisation in the EU on 26 March 2015 for treatment of human immunodeficiency virus (HIV-1). The marketing authorisation was initially valid for a 5-year period.
The European Public Assessment Report (EPAR) for Dutrebis is updated accordingly to indicate that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:-
26/03/2015
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).
Product details
- Name of medicine
- Dutrebis
- 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
- J05AR16
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
News on Dutrebis
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