Atazanavir Mylan

atazanavir

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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.

What is Atazanavir Mylan and what is it used for?

Atazanavir Mylan is an HIV medicine used to treat patients infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immunodeficiency syndrome (AIDS). It is used together with low-dose ritonavir and other antiviral medicines to treat patients aged 6 years and over.

Doctors should prescribe Atazanavir Mylan only after they have looked at which medicines the patient has taken and carried out tests to establish that the virus is likely to respond to Atazanavir Mylan. The medicine is not expected to work in patients in whom many medicines in the same class as Atazanavir Mylan (protease inhibitors) do not work.

Atazanavir Mylan contains the active substance atazanavir.

Atazanavir Mylan is a ‘generic medicine’. This means that Atazanavir Mylan is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Reyataz.

How is Atazanavir Mylan used?

Atazanavir Mylan is available as capsules (150 mg, 200 mg and 300 mg). It can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of HIV infection.

For adults, the recommended dose is 300 mg once a day. In younger patients, the dose of Atazanavir Mylan depends on body weight. Each dose must be taken with food.

Atazanavir Mylan is normally given with ritonavir to boost its action but doctors can consider stopping ritonavir in adults in some specific situations.

How does Atazanavir Mylan work?

The active substance in Atazanavir Mylan, atazanavir, is a protease inhibitor. It blocks an enzyme called protease, which is needed for the virus to multiply. Blocking the enzyme prevents the virus from multiplying, slowing down the spread of infection. A small dose of another medicine, ritonavir, is normally given at the same time as a ‘booster’. Ritonavir slows down the break-down of atazanavir, increasing the levels of atazanavir in the blood. This allows a lower dose of atazanavir to be used for the same antiviral effect. Atazanavir Mylan, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level. Atazanavir Mylan does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.

How has Atazanavir Mylan been studied?

Because Atazanavir Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Reyataz. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Atazanavir Mylan?

Because Atazanavir Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Why is Atazanavir Mylan approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Atazanavir Mylan has been shown to have comparable quality and to be bioequivalent to Reyataz. Therefore, the CHMP’s view was that, as for Reyataz, the benefit outweighs the identified risk. The Committee recommended that Atazanavir Mylan be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Atazanavir Mylan?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Atazanavir Mylan have been included in the summary of product characteristics and the package leaflet.

Other information about Atazanavir Mylan

The European Commission granted a marketing authorisation valid throughout the European Union for Atazanavir Mylan on 22 August 2016.

For more information about treatment with Atazanavir Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Atazanavir Mylan : EPAR - Summary for the public BG = bălgarski 2017-01-31  
Atazanavir Mylan : EPAR - Summary for the public ES = español 2017-01-31  
Atazanavir Mylan : EPAR - Summary for the public CS = čeština 2017-01-31  
Atazanavir Mylan : EPAR - Summary for the public DA = dansk 2017-01-31  
Atazanavir Mylan : EPAR - Summary for the public DE = Deutsch 2017-01-31  
Atazanavir Mylan : EPAR - Summary for the public ET = eesti keel 2017-01-31  
Atazanavir Mylan : EPAR - Summary for the public EL = elliniká 2017-01-31  
Atazanavir Mylan : EPAR - Summary for the public EN = English 2017-01-31  
Atazanavir Mylan : EPAR - Summary for the public FR = français 2017-01-31  
Atazanavir Mylan : EPAR - Summary for the public IT = italiano 2017-01-31  
Atazanavir Mylan : EPAR - Summary for the public LV = latviešu valoda 2017-01-31  
Atazanavir Mylan : EPAR - Summary for the public LT = lietuvių kalba 2017-01-31  
Atazanavir Mylan : EPAR - Summary for the public HU = magyar 2017-01-31  
Atazanavir Mylan : EPAR - Summary for the public MT = Malti 2017-01-31  
Atazanavir Mylan : EPAR - Summary for the public NL = Nederlands 2017-01-31  
Atazanavir Mylan : EPAR - Summary for the public PL = polski 2017-01-31  
Atazanavir Mylan : EPAR - Summary for the public PT = português 2017-01-31  
Atazanavir Mylan : EPAR - Summary for the public RO = română 2017-01-31  
Atazanavir Mylan : EPAR - Summary for the public SK = slovenčina 2017-01-31  
Atazanavir Mylan : EPAR - Summary for the public SL = slovenščina 2017-01-31  
Atazanavir Mylan : EPAR - Summary for the public FI = suomi 2017-01-31  
Atazanavir Mylan : EPAR - Summary for the public SV = svenska 2017-01-31  
Atazanavir Mylan : EPAR - Summary for the public HR = Hrvatski 2017-01-31  

This EPAR was last updated on 31/01/2017 .

Authorisation details

Product details

Product details for Atazanavir Mylan
NameAtazanavir Mylan
Agency product numberEMEA/H/C/004048
Active substance

atazanavir sulfate

International non-proprietary name (INN) or common name

atazanavir

Therapeutic area HIV Infections
Anatomical therapeutic chemical (ATC) code J05AE08
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Atazanavir Mylan
Marketing-authorisation holder

MYLAN S.A.S.

Revision0
Date of issue of marketing authorisation valid throughout the European Union22/08/2016

Contact address:

MYLAN S.A.S.
117 Allée des Parcs 
69800 Saint Priest 
France

Product information

Product information

22/08/2016  Atazanavir Mylan -EMEA/H/C/004048

Name Language First published Last updated
Atazanavir Mylan : EPAR - Product Information HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - Product Information HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - Product Information HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - Product Information HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - Product Information HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - Product Information HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - Product Information HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - Product Information HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - Product Information HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - Product Information HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - Product Information HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - Product Information HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - Product Information HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - Product Information HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - Product Information HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - Product Information HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - Product Information HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - Product Information HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - Product Information HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - Product Information HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - Product Information HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - Product Information HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - Product Information HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - Product Information HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - Product Information HR = Hrvatski 2017-01-31  

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.


Name Language First published Last updated
Atazanavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-01-31  
Atazanavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-01-31  

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

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Atazanavir Mylan : EPAR - Public assessment report HR = Hrvatski 2017-01-31  
CHMP summary of opinion for Atazanavir Mylan HR = Hrvatski 2016-06-24  

Authorised

This medicine is approved for use in the European Union

More information on Atazanavir Mylan