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Questions & Answers

On 9 November 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 Genvoya. The marketing authorisation holder for this medicinal product is Gilead Sciences International Ltd.

The CHMP adopted an extension to the existing indication as follows[1]:

"Genvoya is indicated for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus-1 (HIV-1) infection without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir, as follows: (see sections 4.2 and 5.1).

  • In adults and adolescents aged from 12 years and with body weight at least 35 kg
  • In children aged from 6 years and with body weight at least 25 kg for whom alternative regimens are unsuitable due to resistance or toxicities.

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.

1New text in bold, removed text as strikethrough

Name Language First published Last updated
CHMP post-authorisation summary of positive opinion for Genvoya (II-26) (English only) 2017-11-10  

Key facts

Product details for Genvoya
INN or common name

elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide

Therapeutic area HIV Infections
Active substance

elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide

Date opinion adopted09/11/2017
Company name

Gilead Sciences International Ltd

Application typePost authorisation