Genvoya

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elvitegravir / cobicistat / 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 Genvoya. 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 Genvoya.

For practical information about using Genvoya, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 11/04/2019

Authorisation details

Product details
Name
Genvoya
Agency product number
EMEA/H/C/004042
Active substance
  • elvitegravir
  • cobicistat
  • emtricitabine
  • tenofovir alafenamide
International non-proprietary name (INN) or common name
elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AR
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
19
Date of issue of marketing authorisation valid throughout the European Union
19/11/2015
Contact address

IDA Business & Technology Park
Carrigtohill
County Cork
T45 DP77
Ireland

Product information

28/03/2019 Genvoya - EMEA/H/C/004042 - WS/1401

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

Genvoya is indicated for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus 1 (HIV 1) without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir.

Assessment history

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