Stribild

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Questions & Answers

On 14 September 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 Stribild. The marketing authorisation holder for this medicinal product is Gilead Sciences International Limited.

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

“Stribild is indicated for the treatment of human immunodeficiency virus‑1 (HIV‑1) infection in adults aged 18 years and over who are antiretroviral treatment-naïve or are infected with HIV‑1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild (see sections 4.2, 4.4 and 5.1).

Stribild is also indicated for the treatment of HIV‑1 infection in adolescents aged 12 to < 18 years weighing ≥ 35 kg who are infected with HIV‑1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild and who have experienced toxicities which preclude the use of other regimens that do not contain tenofovir disoproxil fumarate (TDF) (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

Name Language First published Last updated
CHMP post-authorisation summary of positive opinion for Stribild (English only) 2017-09-15  

Key facts

Product details for Stribild
NameStribild
INN or common name

elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil

Therapeutic area HIV Infections
Active substance

elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil fumarate

Date opinion adopted14/09/2017
Company name

Gilead Sciences International Limited

StatusPositive
Application typePost authorisation