Atazanavir Mylan

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atazanavir

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

Overview

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 06/11/2018

Authorisation details

Product details
Name
Atazanavir Mylan
Agency product number
EMEA/H/C/004048
Active substance
atazanavir sulfate
International non-proprietary name (INN) or common name
atazanavir
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AE08
Generic

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 S.A.S.
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
22/08/2016
Contact address
117 Allée des Parcs
69800 Saint Priest
France

Product information

10/10/2018 Atazanavir Mylan - EMEA/H/C/004048 - IB/0006

Contents

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

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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