CHMP recommends Dutrebis (lamivudine/ raltegravir) for treatment of HIV/AIDS-Merck Inc.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Dutrebis, 150 mg lamivudine/300 mg raltegravir, film-coated tablet intended 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. The applicant for this medicinal product is Merck Sharp & Dohme Limited. They may request a re-examination of any CHMP opinion, provided they notify the European Medicines Agency in writing of their intention within 15 days of receipt of the opinion. A pharmacovigilance plan for Dutrebis will be implemented as part of the marketing authorisation.
Learning Zones
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