Basic Information
Odefsey
Regulatory Information
EMEA/H/C/004156
June 21, 2016
April 28, 2016
20
February 20, 2023
Company Information
Ireland
IDA Business & Technology Park Carrigtohill County Cork T45 DP77
GILEAD SCIENCES IRELAND UC
Active Substances Detail
emtricitabinerilpivirine hydrochloridetenofovir alafenamide
EMA Resources
Detailed Information
Therapeutic Indication
### 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.
Overview Summary
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.