Evotaz
atazanavir / cobicistat
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Evotaz. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Evotaz.
For practical information about using Evotaz, patients should read the package leaflet or contact their doctor or pharmacist.
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List item
Evotaz : EPAR - Summary for the public (PDF/110.74 KB)
First published: 10/08/2015
Last updated: 18/11/2021
EMA/355388/2021 -
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Evotaz : EPAR - Risk-management-plan summary (PDF/76.42 KB)
First published: 10/08/2015
Last updated: 10/08/2015
EMA/391330/2015
Authorisation details
Product details | |
---|---|
Name |
Evotaz
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Agency product number |
EMEA/H/C/003904
|
Active substance |
|
International non-proprietary name (INN) or common name |
|
Therapeutic area (MeSH) |
HIV Infections
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Anatomical therapeutic chemical (ATC) code |
J05AR15
|
Publication details | |
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Marketing-authorisation holder |
Bristol-Myers Squibb Pharma EEIG
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Revision |
14
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Date of issue of marketing authorisation valid throughout the European Union |
13/07/2015
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Contact address |
Plaza 254 |
Product information
16/03/2023 Evotaz - EMEA/H/C/003904 - II/0044
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
Antivirals for systemic use
Therapeutic indication
EVOTAZ is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults and adolescents (aged 12 years and older weighing at least 35 kg) without known mutations associated with resistance to atazanavir (see sections 4.4 and 5.1).