Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 08 June 2018

Indication(s)

EDURANT, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve patients 12 years of age and older with a viral load ≤ 100,000 HIV-1 RNA copies/ml.

Genotypic resistance testing should guide the use of EDURANT.

Full Prescribing information

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Category Value
Agency product number EMEA/H/C/002264
Orphan designation No
Date First Approved 28-11-2011
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Janssen-Cilag International N.V.
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