Evotaz

atazanavir / cobicistat

Table of contents

Opinion

On 20 May 2021, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Evotaz. The marketing authorisation holder for this medicinal product is Bristol-Myers Squibb Pharma EEIG.

The CHMP adopted an extension to the existing indication as follows:1

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).

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1 New text in bold

Key facts

Name
Evotaz
Agency product number
EMEA/H/C/003904
International non-proprietary name (INN) or common name
  • atazanavir
  • cobicistat
Active substance
  • cobicistat
  • atazanavir sulfate
Therapeutic area
HIV Infections
Date opinion adopted
21/05/2021
Company name
Bristol-Myers Squibb Pharma EEIG
Status
Positive
Application type
Post-authorisation

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