darunavir / cobicistat / emtricitabine / tenofovir alafenamide
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.
Symtuza : EPAR - Medicine overview (PDF/82.2 KB)
First published: 26/09/2017
Last updated: 11/10/2019
Symtuza : EPAR - Risk management plan summary (PDF/120.91 KB)
First published: 28/03/2022
Last updated: 14/09/2022
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Janssen-Cilag International NV
|Date of issue of marketing authorisation valid throughout the European Union||
01/09/2022 Symtuza - EMEA/H/C/004391 - II/0045
This medicine’s product information is available in all official EU languages.
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.
Antivirals for systemic use
Antivirals for treatment of HIV infections, combinations
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.