Positive EC Decision: Emtricitabine / Rilpivirine / Tenofovir Alafenamide Viatris (Gx Odefsey)

On 19 August 2025, the European Commission (EC) granted the Marketing Authorization (MA) for the medicinal product "Emtricitabine / Rilpivirine / Tenofovir Alafenamide Viatris”, a generic of ODEFSEY.

Emtricitabine / Rilpivirine / Tenofovir Alafenamide Viatris is an antiviral medicine used in combination with other medicines to treat people infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). It is used in adults and adolescents aged 12 years and older who weigh at least 35 kg.

Emtricitabine / Rilpivirine / Tenofovir Alafenamide Viatris contains the active substances emtricitabine / rilpivirine / tenofovir and is a ‘generic medicine’. This means that this medicine contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Emtricitabine / Rilpivirine / Tenofovir Alafenamide Viatris is Odefsey. For more information on generic medicines, see the question-and-answer document here.