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 12/10/2018

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
05AR09
Publication details
Marketing-authorisation holder
Gilead Sciences Ireland UC
Revision
19
Date of issue of marketing authorisation valid throughout the European Union
24/05/2013
Contact address
Carrigtohill
County Cork, T45 DP77
Ireland

Product information

13/09/2018 Stribild - EMEA/H/C/002574 - IG/0983

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

  • Antivirals for treatment of HIV infections
  • combinations

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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