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 13/10/2021

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
Publication details
Marketing-authorisation holder
Gilead Sciences Ireland UC
Revision
25
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

02/09/2021 Genvoya - EMEA/H/C/004042 - WS/2039

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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