Evotaz

RSS

atazanavir / cobicistat

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 18/02/2022

Authorisation details

Product details
Name
Evotaz
Agency product number
EMEA/H/C/003904
Active substance
  • cobicistat
  • atazanavir
International non-proprietary name (INN) or common name
  • atazanavir
  • cobicistat
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AR15
Publication details
Marketing-authorisation holder
Bristol-Myers Squibb Pharma EEIG
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
13/07/2015
Contact address

Plaza 254
Blanchardstown Corporate Park 2
Dublin 15
D15 T867
Ireland

Product information

16/02/2022 Evotaz - EMEA/H/C/003904 - IAIN/0041

Product information documents contain:

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).

Assessment history

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