Data from EMA (European Medicines Agency) - Curated by Toby Galbraith - Last updated 12 October 2017

Indication(s)

Odefsey 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.

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Category Value
Agency product number EMEA/H/C/004156
Orphan designation No
Date First Approved 21-06-2016
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Gilead Sciences International Ltd