darunavir / cobicistat / emtricitabine / tenofovir alafenamide

This medicine is authorised for use in the European Union.


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

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

This EPAR was last updated on 05/12/2018

Authorisation details

Product details
Agency product number
Active substance
  • darunavir
  • cobicistat
  • emtricitabine
  • tenofovir alafenamide
International non-proprietary name (INN) or common name
darunavir / cobicistat / emtricitabine / tenofovir alafenamide
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
B-2340 Beerse

Product information

20/11/2018 Symtuza - EMEA/H/C/004391 - WS/1474/G


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Pharmacotherapeutic group

  • Antivirals for systemic use

  • antivirals for treatment of HIV infection
  • combinations

Therapeutic indication

Symtuza is indicated for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection in adults and adolescents (aged 12 years and older with body weight at least 40 kg).

Genotypic testing should guide the use of Symtuza (see sections 4.2 and 5.1).

Assessment history

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