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 11/04/2018

Authorisation details

Product details
Name
Evotaz
Agency product number
EMEA/H/C/003904
Active substance
  • atazanavir sulfate
  • cobicistat
International non-proprietary name (INN) or common name
atazanavir / cobicistat
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AR
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
Marketing-authorisation holder
Bristol-Myers Squibb Pharma EEIG
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
13/07/2015
Contact address
Uxbridge Business Park
Sanderson Road
Uxbridge UB8 1DH
United Kingdom

Product information

22/02/2018 Evotaz - EMEA/H/C/003904 - WS/1292

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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 without known mutations associated with resistance to atazanavir.

Assessment history

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