Symtuza

RSS

darunavir / cobicistat / emtricitabine / tenofovir alafenamide

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

Overview

Symtuza is an antiviral medicine used to treat human immunodeficiency virus type 1 (HIV-1) in adults and adolescents aged from 12 years (and weighing at least 40 kg). HIV-1 is a virus that causes acquired immune deficiency syndrome (AIDS). 

Symtuza contains the active substances darunavir, cobicistat, emtricitabine and tenofovir alafenamide.

This EPAR was last updated on 09/06/2022

Authorisation details

Product details
Name
Symtuza
Agency product number
EMEA/H/C/004391
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
J05
Publication details
Marketing-authorisation holder
Janssen-Cilag International NV
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
21/09/2017
Contact address

Turnhoutseweg 30
B-2340 Beerse
Belgium

Product information

24/05/2022 Symtuza - EMEA/H/C/004391 - R/0040

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

  • Antivirals for treatment of HIV infections, 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.

Assessment history

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