Odefsey

RSS

emtricitabine / rilpivirine / tenofovir alafenamide

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

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.

This EPAR was last updated on 10/11/2022

Authorisation details

Product details
Name
Odefsey
Agency product number
EMEA/H/C/004156
Active substance
  • emtricitabine
  • rilpivirine hydrochloride
  • tenofovir alafenamide
International non-proprietary name (INN) or common name
  • emtricitabine
  • rilpivirine
  • tenofovir alafenamide
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AR19
Publication details
Marketing-authorisation holder
Gilead Sciences Ireland UC
Revision
19
Date of issue of marketing authorisation valid throughout the European Union
21/06/2016
Contact address

IDA Business & Technology Park
Carrigtohill
County Cork
T45 DP77
Ireland

Product information

10/11/2022 Odefsey - EMEA/H/C/004156 - WS2331

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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 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.

Assessment history

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