Descovy

RSS

emtricitabine / tenofovir alafenamide

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 12/10/2018

Authorisation details

Product details
Name
Descovy
Agency product number
EMEA/H/C/004094
Active substance
  • emtricitabine
  • tenofovir alafenamide
International non-proprietary name (INN) or common name
emtricitabine / tenofovir alafenamide
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AR17
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Gilead Sciences Ireland UC
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
21/04/2016
Contact address

IDA Business & Technology Park
Carrigtohill
County Cork
T45 DP77
Ireland

Product information

13/09/2018 Descovy - EMEA/H/C/004094 - IG/0983

Contents

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You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

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) (see sections 4.2 and 5.1).

Assessment history

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