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Active Substance: lamivudine / raltegravir potassium
Common Name: lamivudine / raltegravir potassium
ATC Code: J05AR16
Marketing Authorisation Holder: Merck Sharp & Dohme Limited
Active Substance: lamivudine / raltegravir potassium
Status: Withdrawn
Authorisation Date: 2015-03-26
Therapeutic Area: HIV Infections
Pharmacotherapeutic Group: 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).

The marketing authorisation for Dutrebis has been withdrawn at the request of the marketing authorisation holder. 

Source: European Medicines Agency

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