Ritonavir Mylan

ritonavir

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

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

What is Ritonavir Mylan and what is it used for?

Ritonavir Mylan is used in combination with other medicines to treat patients over two years of age who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).

Ritonavir Mylan contains the active substance ritonavir and is a ‘generic medicine’. This means that Ritonavir Mylan contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the European Union (EU) called Norvir.

How is Ritonavir Mylan used?

Ritonavir Mylan can only be obtained with a prescription and treatment with Ritonavir Mylan should be given by a doctor who has experience in the treatment of HIV infection. It is available as tablets (100 mg) and should be taken with food.

Ritonavir Mylan can be used as a ‘pharmacokinetic enhancer’ (booster) to increase the blood levels of other antiviral medicines that belong to the same group as Ritonavir Mylan (protease inhibitors) including amprenavir, atazanavir, darunavir, fosamprenavir, lopinavir, saquinavir, and tipranavir. The usual dose of Ritonavir Mylan for adults is 100 or 200 mg, once or twice a day. The dose depends on which other protease inhibitor is being taken. For more information, see the package leaflet provided with the other medicine.

Ritonavir Mylan can also be used in larger doses for a direct antiviral effect on HIV. The recommended dose for adults (aged 18 years or over) is 600 mg twice a day. For younger patients, the recommended dose depends on the patient’s height and weight. Treatment should start with a low dose that is gradually increased over the first 14 days of treatment.

How does Ritonavir Mylan work?

As a ‘booster’, the active substance ritonavir slows the breakdown of other protease inhibitor antivirals. This increases the levels of these protease inhibitors in the blood and enhances their antiviral effect.

At higher antiviral doses, ritonavir is a ‘protease inhibitor’. This means that it blocks a viral enzyme called protease, which is involved in the multiplication of HIV. When the enzyme is blocked, the virus can no longer multiply normally, slowing down its spread. Ritonavir Mylan, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level. Ritonavir Mylan does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.

How has Ritonavir Mylan been studied?

Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Norvir, and do not need to be repeated for Ritonavir Mylan.

As for every medicine, the company provided studies on the quality of Ritonavir Mylan. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Ritonavir Mylan?

Because Ritonavir 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 Ritonavir Mylan approved?

The European Medicines Agency concluded that, in accordance with EU requirements, Ritonavir Mylan has been shown to have comparable quality and to be bioequivalent to Norvir. Therefore, the Agency’s view was that, as for Norvir, the benefit outweighs the identified risk. The Agency recommended that Ritonavir Mylan be approved for use in the EU.

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

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

Other information about Ritonavir Mylan

The European Commission granted a marketing authorisation valid throughout the European Union for Ritonavir Mylan on 10 November 2017.

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

Name Language First published Last updated
Ritonavir Mylan : EPAR - Summary for the public BG = bălgarski 2017-11-20  
Ritonavir Mylan : EPAR - Summary for the public ES = español 2017-11-20  
Ritonavir Mylan : EPAR - Summary for the public CS = čeština 2017-11-20  
Ritonavir Mylan : EPAR - Summary for the public DA = dansk 2017-11-20  
Ritonavir Mylan : EPAR - Summary for the public DE = Deutsch 2017-11-20  
Ritonavir Mylan : EPAR - Summary for the public ET = eesti keel 2017-11-20  
Ritonavir Mylan : EPAR - Summary for the public EL = elliniká 2017-11-20  
Ritonavir Mylan : EPAR - Summary for the public EN = English 2017-11-20  
Ritonavir Mylan : EPAR - Summary for the public FR = français 2017-11-20  
Ritonavir Mylan : EPAR - Summary for the public IT = italiano 2017-11-20  
Ritonavir Mylan : EPAR - Summary for the public LV = latviešu valoda 2017-11-20  
Ritonavir Mylan : EPAR - Summary for the public LT = lietuvių kalba 2017-11-20  
Ritonavir Mylan : EPAR - Summary for the public HU = magyar 2017-11-20  
Ritonavir Mylan : EPAR - Summary for the public MT = Malti 2017-11-20  
Ritonavir Mylan : EPAR - Summary for the public NL = Nederlands 2017-11-20  
Ritonavir Mylan : EPAR - Summary for the public PL = polski 2017-11-20  
Ritonavir Mylan : EPAR - Summary for the public PT = português 2017-11-20  
Ritonavir Mylan : EPAR - Summary for the public RO = română 2017-11-20  
Ritonavir Mylan : EPAR - Summary for the public SK = slovenčina 2017-11-20  
Ritonavir Mylan : EPAR - Summary for the public SL = slovenščina 2017-11-20  
Ritonavir Mylan : EPAR - Summary for the public FI = suomi 2017-11-20  
Ritonavir Mylan : EPAR - Summary for the public SV = svenska 2017-11-20  
Ritonavir Mylan : EPAR - Summary for the public HR = Hrvatski 2017-11-20  

This EPAR was last updated on 20/11/2017 .

Authorisation details

Product details

Product details for Ritonavir Mylan
NameRitonavir Mylan
Agency product numberEMEA/H/C/004549
Active substance

ritonavir

International non-proprietary name (INN) or common name

ritonavir

Therapeutic area HIV Infections
Anatomical therapeutic chemical (ATC) code J05AE03
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 Ritonavir Mylan
Marketing-authorisation holder

MYLAN S.A.S

Revision0
Date of issue of marketing authorisation valid throughout the European Union10/11/2017

Contact address:

117 Allée des Parcs 
69800 Saint-Priest 
France

Product information

Product information

10/11/2017  Ritonavir Mylan -EMEA/H/C/004549

Name Language First published Last updated
Ritonavir Mylan : EPAR - Product Information HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - Product Information HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - Product Information HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - Product Information HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - Product Information HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - Product Information HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - Product Information HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - Product Information HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - Product Information HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - Product Information HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - Product Information HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - Product Information HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - Product Information HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - Product Information HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - Product Information HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - Product Information HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - Product Information HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - Product Information HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - Product Information HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - Product Information HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - Product Information HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - Product Information HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - Product Information HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - Product Information HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - Product Information HR = Hrvatski 2017-11-20  

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
Ritonavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-20  
Ritonavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-20  

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV 1 infected patients (adults and children of 2 years of age and older).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Ritonavir Mylan : EPAR - Public assessment report HR = Hrvatski 2017-11-20  
CHMP summary of positive opinion for Ritonavir Mylan HR = Hrvatski 2017-09-15  

Authorised

This medicine is approved for use in the European Union

More information on Ritonavir Mylan