emtricitabine / rilpivirine / tenofovir alafenamide
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.
Odefsey : EPAR - Summary for the public (PDF/82.76 KB)
First published: 08/07/2016
Last updated: 08/07/2016
Odefsey : EPAR - Risk-management-plan summary (PDF/197.04 KB)
First published: 21/01/2021
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Gilead Sciences Ireland UC
|Date of issue of marketing authorisation valid throughout the European Union||
IDA Business & Technology Park
14/01/2021 Odefsey - EMEA/H/C/004156 - R/0049
- 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.
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Antivirals for systemic use
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.