darunavir / cobicistat

This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for Rezolsta. 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 Rezolsta.

For practical information about using Rezolsta, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 16/08/2019

Authorisation details

Product details
Agency product number
Active substance
  • darunavir
  • cobicistat
International non-proprietary name (INN) or common name
darunavir / cobicistat
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
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
Janssen-Cilag International N.V.
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Turnhoutseweg 30
2340 Beerse

Product information

31/07/2019 Rezolsta - EMEA/H/C/002819 - R/0031


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Pharmacotherapeutic group

Film coated tablet

Therapeutic indication

Rezolsta, is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus 1 (HIV 1) infection in adults aged 18 years or older.

Genotypic testing should guide the use of Rezolsta.

Assessment history

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