Biktarvy

RSS

bictegravir / emtricitabine / tenofovir alafenamide

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

Overview

An overview of Biktarvy and why it is authorised in the EU

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

Biktarvy contains the active substances bictegravir, emtricitabine and tenofovir alafenamide. It is only used in patients where the virus has not developed resistance to a class of HIV medicines called integrase inhibitors, or to tenofovir or emtricitabine.

This EPAR was last updated on 22/06/2018

Authorisation details

Product details
Name
Biktarvy
Agency product number
EMEA/H/C/004449
Active substance
  • bictegravir
  • emtricitabine
  • tenofovir alafenamide
  • fumarate
International non-proprietary name (INN) or common name
bictegravir / emtricitabine / tenofovir alafenamide
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AR
Additional 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 International Limited
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
20/06/2018
Contact address
Flowers Building
Granta Park
Abington
Cambridge CB21 6GT
United Kingdom

Product information

21/06/2018 Biktarvy - EMEA/H/C/004449 -

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

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

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Biktarvy is indicated for the treatment of adults infected with human immunodeficiency virus 1 (HIV 1) without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir.

Assessment history

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