Truvada

RSS

emtricitabine / tenofovir disoproxil

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

Overview

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

Truvada is used in combination with at least one other HIV medicine to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). In addition it may be used from the age of 12 in adolescents with HIV who are resistant to first-line treatments or who cannot take them because of side effects.

Truvada is also used to help prevent sexually transmitted HIV-1 infection in adults and adolescents who are at high risk of being infected (pre-exposure prophylaxis or PrEP). It should be used in combination with safer sex practices, such as use of condoms.

Truvada contains two active substances, emtricitabine (200 mg) and tenofovir disoproxil (245 mg).

This EPAR was last updated on 18/09/2018

Authorisation details

Product details
Name
Truvada
Agency product number
EMEA/H/C/000594
Active substance
  • emtricitabine
  • tenofovir disoproxil fumarate
International non-proprietary name (INN) or common name
emtricitabine / tenofovir disoproxil
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AR03
Publication details
Marketing-authorisation holder
Gilead Sciences Ireland UC
Revision
38
Date of issue of marketing authorisation valid throughout the European Union
21/02/2005
Contact address
Carrigtohill
County Cork, T45 DP77
Ireland

Product information

19/07/2017 Truvada - EMEA/H/C/000594 - WS/1351

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

Treatment of HIV-1 infection:
Truvada is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults.

Truvada is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years.

Pre-exposure prophylaxis (PrEP):
Truvada is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.

Assessment history

Changes since initial authorisation of medicine

How useful was this page?

Add your rating