Odefsey
emtricitabine / rilpivirine / tenofovir alafenamide
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Odefsey. 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 Odefsey.
For practical information about using Odefsey, patients should read the package leaflet or contact their doctor or pharmacist.
-
List item
Odefsey : EPAR - Summary for the public (PDF/82.76 KB)
First published: 08/07/2016
Last updated: 08/07/2016
EMA/322559/2016 -
-
List item
Odefsey : EPAR - Risk-management-plan summary (PDF/197.04 KB)
First published: 21/01/2021
Authorisation details
Product details | |
---|---|
Name |
Odefsey
|
Agency product number |
EMEA/H/C/004156
|
Active substance |
|
International non-proprietary name (INN) or common name |
|
Therapeutic area (MeSH) |
HIV Infections
|
Anatomical therapeutic chemical (ATC) code |
J05AR19
|
Publication details | |
---|---|
Marketing-authorisation holder |
Gilead Sciences Ireland UC
|
Revision |
20
|
Date of issue of marketing authorisation valid throughout the European Union |
21/06/2016
|
Contact address |
IDA Business & Technology Park |
Product information
16/02/2023 Odefsey - EMEA/H/C/004156 - IG/1588
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 systemic use
Therapeutic indication
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) without known mutations associated with resistance to the non nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine and with a viral load ≤ 100,000 HIV 1 RNA copies/mL.