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Questions & Answers

On 14 December 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Truvada. The marketing authorisation holder for this medicinal product is Gilead Sciences International Limited.

The CHMP adopted an extension to an existing indication as follows1:

Treatment of HIV‑1 infection:

Truvada is indicated in antiretroviral combination therapy for the treatment of HIV‑1 infected adults (see section 5.1).

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 (see sections 4.2, 4.4 and 5.1).

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 and adolescents at high risk (see sections 4.2, 4.4 and 5.1).”

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

1 New text in bold, removed text as strikethrough

Name Language First published Last updated
CHMP post-authorisation summary of positive opinion for Truvada (II-135) (English only) 2017-12-15  

Key facts

Product details for Truvada
INN or common name

emtricitabine / tenofovir disoproxil

Therapeutic area HIV Infections
Active substance

emtricitabine / tenofovir disoproxil fumarate

Date opinion adopted14/12/2017
Company name

Gilead Sciences International Limited.

Application typePost authorisation