Stribild
elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil
Table of contents
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.
-
List item
Stribild : EPAR - Summary for the public (PDF/79.48 KB)
First published: 13/06/2013
Last updated: 23/10/2017
EMA/200486/2013 -
-
List item
Stribild : EPAR - Risk management plan summary (PDF/132.88 KB)
First published: 02/02/2023
Authorisation details
Product details | |
---|---|
Name |
Stribild
|
Agency product number |
EMEA/H/C/002574
|
Active substance |
|
International non-proprietary name (INN) or common name |
|
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 |
Product information
12/01/2023 Stribild - EMEA/H/C/002574 - WS/2320
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
News
-
15/09/2017
-
23/10/2015
-
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 October 201523/10/2015