Odefsey

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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 09/10/2018

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
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Gilead Sciences Ireland UC
Revision
13
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

13/09/2018 Odefsey - EMEA/H/C/004156 - IG/0983

Contents

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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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