emtricitabine / tenofovir disoproxil
Table of contents
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).
Truvada : EPAR - Medicine overview (PDF/81.38 KB)
First published: 03/07/2007
Last updated: 14/03/2018
Truvada : EPAR - Risk-management-plan summary (PDF/178.87 KB)
First published: 14/05/2019
Last updated: 02/02/2023
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Gilead Sciences Ireland UC
|Date of issue of marketing authorisation valid throughout the European Union||
IDA Business & Technology Park
12/01/2023 Truvada - EMEA/H/C/000594 - WS/2320
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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).
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Antivirals for systemic use
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.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 December 201715/12/2017
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 February 201724/02/2017
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 October 201523/10/2015