8 July 2016 - The EMA has published an EPAR for Gilead Sciences' Odefsey.

The European Commission approved Odefsey (emtricitabine with rilpivirine hydrochloride and tenofovir alafenamide fumarate) on 21 June 2016 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.

Odefsey will be subjected to additional monitoring by the EMA.

View EPAR for Odefsey