Licensing authority

EMA (European Medicines Agency)

Indication(s)

Eviplera is indicated for the treatment of adults infected with human immunodeficiency virus type 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.

Genotypic resistance testing and/or historical resistance data should guide the use of Eviplera.

Full Prescribing information

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More information

Category Value
Agency product number EMEA/H/C/002312
Orphan designation
Date First Approved 28-11-2011
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Gilead Sciences International Ltd.
Warnings

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reacti