Stribild

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elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil

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

Overview

This is a summary of the European public assessment report (EPAR) for Stribild. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Stribild.

For practical information about using Stribild, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 02/02/2023

Authorisation details

Product details
Name
Stribild
Agency product number
EMEA/H/C/002574
Active substance
  • elvitegravir
  • cobicistat
  • emtricitabine
  • tenofovir disoproxil fumarate
International non-proprietary name (INN) or common name
  • elvitegravir
  • cobicistat
  • emtricitabine
  • tenofovir disoproxil
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AR09
Publication details
Marketing-authorisation holder
Gilead Sciences Ireland UC
Revision
25
Date of issue of marketing authorisation valid throughout the European Union
24/05/2013
Contact address

IDA Business & Technology Park
Carrigtohill
County Cork
T45 DP77
Ireland

Product information

12/01/2023 Stribild - EMEA/H/C/002574 - WS/2320

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

  • Antivirals for treatment of HIV infections, combinations
  • Antivirals for systemic use

Therapeutic indication

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.

Assessment history

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