Atazanavir Mylan
atazanavir
Table of contents
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.
Authorisation details
Product details | |
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Name |
Atazanavir Mylan
|
Agency product number |
EMEA/H/C/004048
|
Active substance |
atazanavir (as 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 | |
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Marketing-authorisation holder |
Mylan S.A.S.
|
Revision |
9
|
Date of issue of marketing authorisation valid throughout the European Union |
22/08/2016
|
Contact address |
Product information
20/11/2020 Atazanavir Mylan - EMEA/H/C/004048 - IA/0015
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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
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.