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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List item
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/92.22 KB)
First published: 24/05/2018
Last updated: 11/10/2019
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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Additional 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 | |
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Marketing-authorisation holder |
Janssen-Cilag International N.V.
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Revision |
9
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Date of issue of marketing authorisation valid throughout the European Union |
21/09/2017
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Contact address |
Product information
20/01/2021 Symtuza - EMEA/H/C/004391 - IB/0029
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
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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.