Positive CHMP Opinion: Emtricitabine / Rilpivirine / Tenofovir Alafenamide Viatris (generic drug of Odefsey)
On 19 June 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Emtricitabine/rilpivirine/tenofovir alafenamide Viatris, intended for treatment of adults and adolescents infected with human immunodeficiency virus type 1 (HIV-1). The applicant for this medicinal product is Viatris Limited.
Emtricitabine/rilpivirine/tenofovir alafenamide Viatris is a generic of Odefsey, which has been authorised in the EU since 21 June 2016. Studies have demonstrated the satisfactory quality of Emtricitabine/rilpivirine/tenofovir alafenamide Viatris, and its bioequivalence to the reference product Odefsey.
The full indication is:
Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris is indicated for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus-1 (HIV-1) without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine and with a viral load ≤ 100 000 HIV‑1 RNA copies/mL (see sections 4.2, 4.4 and 5.1).
Additional information to the following link: Emtricitabine / Rilpivirine / Tenofovir Alafenamide Viatris | European Medicines Agency (EMA)