Biktarvy

RSS

bictegravir / emtricitabine / tenofovir alafenamide

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

Overview

Biktarvy is an antiviral medicine used to treat adults and children from 2 years of age and weighing at least 14 kg 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 23/01/2023

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
J05AR20
Publication details
Marketing-authorisation holder
Gilead Sciences Ireland UC
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
21/06/2018
Contact address

IDA Business & Technology Park
Carrigtohill
County Cork
T45 DP77
Ireland

Product information

10/01/2023 Biktarvy - EMEA/H/C/004449 - R/0052

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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

Biktarvy is indicated for the treatment of human immunodeficiency virus 1 (HIV 1) infection in adults and paediatric patients at least 2 years of age and weighing at least 14 kg i without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir.(see section 5.1)

Assessment history

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