Genvoya
elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide
Table of contents
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.
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List item
Genvoya : EPAR - Summary for the public (PDF/122.76 KB)
First published: 01/12/2015
Last updated: 08/11/2022
EMA/676172/2022 -
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List item
Genvoya : EPAR - Risk-management-plan summary (PDF/236.1 KB)
First published: 01/12/2015
Last updated: 14/10/2022
Authorisation details
Product details | |
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Name |
Genvoya
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Agency product number |
EMEA/H/C/004042
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Active substance |
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International non-proprietary name (INN) or common name |
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Therapeutic area (MeSH) |
HIV Infections
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Anatomical therapeutic chemical (ATC) code |
J05AR
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Publication details | |
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Marketing-authorisation holder |
Gilead Sciences Ireland UC
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Revision |
27
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Date of issue of marketing authorisation valid throughout the European Union |
19/11/2015
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Contact address |
IDA Business & Technology Park |
Product information
03/10/2022 Genvoya - EMEA/H/C/004042 - X/0079/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.