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 11/10/2019

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
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.
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
21/09/2017
Contact address

Turnhoutseweg 30
B-2340 Beerse
Belgium

Product information

01/07/2019 Symtuza - EMEA/H/C/004391 - II/0017/G

Contents

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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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