emtricitabine / tenofovir alafenamide
This is a summary of the European public assessment report (EPAR) for Descovy. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Descovy.
For practical information about using Descovy, patients should read the package leaflet or contact their doctor or pharmacist.
Descovy : EPAR - Summary for the public (PDF/75.65 KB)
First published: 01/06/2016
Last updated: 01/06/2016
Descovy : EPAR - Risk-management-plan summary (PDF/176.66 KB)
First published: 17/03/2020
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Gilead Sciences Ireland UC
|Date of issue of marketing authorisation valid throughout the European Union||
11/02/2021 Descovy - EMEA/H/C/004094 - R/0051
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Antivirals for systemic use
Descovy is indicated in combination with other antiretroviral agents for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus type 1 (HIV-1).