Atazanavir Mylan



This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for Atazanavir Mylan. 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 Atazanavir Mylan.

For practical information about using Atazanavir Mylan, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 17/05/2023

Authorisation details

Product details
Atazanavir Mylan
Agency product number
Active substance
atazanavir (as sulfate)
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Mylan Pharmaceuticals Limited
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Mylan Pharmaceuticals Limited
Damastown Industrial Park
Dublin 15

Product information

16/05/2023 Atazanavir Mylan - EMEA/H/C/004048 - IAIN/0025

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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

Atazanavir Mylan, co-administered with low dose ritonavir, is indicated for the treatment of HIV 1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products.

Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors (≥ 4 PI mutations). There are very limited data available from children aged 6 to less than 18 years.

The choice of Atazanavir Mylan in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history.

Assessment history

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