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CHMP recommends granting extension of indication to Eviplera

The Committee for Medicinal Products for Human Use adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal product Eviplera. The marketing authorisation holder for this medicinal product is Gilead Sciences International. The CHMP adopted a change to the indication as follows: "Eviplera is indicated for the treatment of adults infected with human immunodeficiency virus type 1 without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor class, tenofovir or emtricitabine, and in antiretroviral treatment-naïve adult patients with a viral load ≤ 100,000 HIV 1 RNA copies/mL."