Symtuza
darunavir / cobicistat / emtricitabine / tenofovir alafenamide
Table of contents
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.
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Symtuza : EPAR - Medicine overview (PDF/82.2 KB)
First published: 26/09/2017
Last updated: 11/10/2019 -
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Symtuza : EPAR - Risk management plan summary (PDF/120.91 KB)
First published: 28/03/2022
Last updated: 14/09/2022
Authorisation details
Product details | |
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Name |
Symtuza
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Agency product number |
EMEA/H/C/004391
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Active substance |
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International non-proprietary name (INN) or common name |
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Therapeutic area (MeSH) |
HIV Infections
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Anatomical therapeutic chemical (ATC) code |
J05
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Publication details | |
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Marketing-authorisation holder |
Janssen-Cilag International NV
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Revision |
17
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Date of issue of marketing authorisation valid throughout the European Union |
21/09/2017
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Contact address |
Turnhoutseweg 30 |
Product information
07/03/2023 Symtuza - EMEA/H/C/004391 - IB/0049
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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.
Pharmacotherapeutic group
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Antivirals for systemic use
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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.