Genvoya

RSS

elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide

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

Overview

Genvoya is an antiviral medicine used to treat individuals infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).

It is used in adults and children from 2 years of age and weighing at least 14 kg whose disease is not expected to be resistant to any of the antiviral substances in Genvoya.

Genvoya contains the active substances elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide.

This EPAR was last updated on 28/11/2022

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
27
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

03/10/2022 Genvoya - EMEA/H/C/004042 - X/0079/G

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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

Changes since initial authorisation of medicine

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