Yargesa

miglustat

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

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

What is Yargesa and what is it used for?

Yargesa is a medicine used to treat adults with mild to moderate type-1 Gaucher disease.

Patients with this disease lack an enzyme that breaks down a type of fat called glucosylceramide. As a result, glucosylceramide builds up in different parts of the body, such as the spleen, liver and bones. Yargesa is used in patients who cannot receive enzyme-replacement therapy.

Yargesa is a ‘generic medicine’. This means that it contains the same active substance (miglustat) and works in the same way as a ‘reference medicine’ already authorised in the European Union (EU) called Zavesca.

How is Yargesa used?

Yargesa is available as 100 mg capsules to be taken by mouth. The recommended starting dose is one capsule three times a day. A lower dose should be used in patients with reduced kidney function and those who develop diarrhoea.

The medicine can only be obtained with a prescription and treatment should be supervised by doctors who are experienced in the management of Gaucher disease.

For more information, see the package leaflet.

How does Yargesa work?

The active substance in Yargesa, miglustat, prevents an enzyme called glucosylceramide synthase from working. This enzyme is involved in the first step of the production of glucosylceramide. By preventing the enzyme from working, miglustat can reduce the production of glucosylceramide in cells, thereby reducing the symptoms of type-1 Gaucher disease.

How has Yargesa been studied?

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

As for every medicine, the company provided studies on the quality of Yargesa. 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 Yargesa?

Because Yargesa 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 Yargesa approved?

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

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

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

Other information about Yargesa

The European Commission granted a marketing authorisation valid throughout the European Union for Yargesa on 22 March 2017.

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

Name Language First published Last updated
Yargesa : EPAR - Summary for the public BG = bălgarski 2017-04-10  
Yargesa : EPAR - Summary for the public ES = español 2017-04-10  
Yargesa : EPAR - Summary for the public CS = čeština 2017-04-10  
Yargesa : EPAR - Summary for the public DA = dansk 2017-04-10  
Yargesa : EPAR - Summary for the public DE = Deutsch 2017-04-10  
Yargesa : EPAR - Summary for the public ET = eesti keel 2017-04-10  
Yargesa : EPAR - Summary for the public EL = elliniká 2017-04-10  
Yargesa : EPAR - Summary for the public EN = English 2017-04-10  
Yargesa : EPAR - Summary for the public FR = français 2017-04-10  
Yargesa : EPAR - Summary for the public IT = italiano 2017-04-10  
Yargesa : EPAR - Summary for the public LV = latviešu valoda 2017-04-10  
Yargesa : EPAR - Summary for the public LT = lietuvių kalba 2017-04-10  
Yargesa : EPAR - Summary for the public HU = magyar 2017-04-10  
Yargesa : EPAR - Summary for the public MT = Malti 2017-04-10  
Yargesa : EPAR - Summary for the public NL = Nederlands 2017-04-10  
Yargesa : EPAR - Summary for the public PL = polski 2017-04-10  
Yargesa : EPAR - Summary for the public PT = português 2017-04-10  
Yargesa : EPAR - Summary for the public RO = română 2017-04-10  
Yargesa : EPAR - Summary for the public SK = slovenčina 2017-04-10  
Yargesa : EPAR - Summary for the public SL = slovenščina 2017-04-10  
Yargesa : EPAR - Summary for the public FI = suomi 2017-04-10  
Yargesa : EPAR - Summary for the public SV = svenska 2017-04-10  
Yargesa : EPAR - Summary for the public HR = Hrvatski 2017-04-10  

This EPAR was last updated on 10/04/2017 .

Authorisation details

Product details

Product details for Yargesa
NameYargesa
Agency product numberEMEA/H/C/004016
Active substance

miglustat

International non-proprietary name (INN) or common name

miglustat

Therapeutic area Gaucher Disease
Anatomical therapeutic chemical (ATC) code A16AX06
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 Yargesa
Marketing-authorisation holder

JensonR+ Limited

Revision0
Date of issue of marketing authorisation valid throughout the European Union22/03/2017

Contact address:

JensonR+ Limited
Fishleigh Court 
Fishleigh Road 
Barnstaple EX31 3UD
United Kingdom

Product information

Product information

22/03/2017  Yargesa -EMEA/H/C/004016 --

Name Language First published Last updated
Yargesa : EPAR - Product Information HR = Hrvatski 2017-04-10  
Yargesa : EPAR - Product Information HR = Hrvatski 2017-04-10  
Yargesa : EPAR - Product Information HR = Hrvatski 2017-04-10  
Yargesa : EPAR - Product Information HR = Hrvatski 2017-04-10  
Yargesa : EPAR - Product Information HR = Hrvatski 2017-04-10  
Yargesa : EPAR - Product Information HR = Hrvatski 2017-04-10  
Yargesa : EPAR - Product Information HR = Hrvatski 2017-04-10  
Yargesa : EPAR - Product Information HR = Hrvatski 2017-04-10  
Yargesa : EPAR - Product Information HR = Hrvatski 2017-04-10  
Yargesa : EPAR - Product Information HR = Hrvatski 2017-04-10  
Yargesa : EPAR - Product Information HR = Hrvatski 2017-04-10  
Yargesa : EPAR - Product Information HR = Hrvatski 2017-04-10  
Yargesa : EPAR - Product Information HR = Hrvatski 2017-04-10  
Yargesa : EPAR - Product Information HR = Hrvatski 2017-04-10  
Yargesa : EPAR - Product Information HR = Hrvatski 2017-04-10  
Yargesa : EPAR - Product Information HR = Hrvatski 2017-04-10  
Yargesa : EPAR - Product Information HR = Hrvatski 2017-04-10  
Yargesa : EPAR - Product Information HR = Hrvatski 2017-04-10  
Yargesa : EPAR - Product Information HR = Hrvatski 2017-04-10  
Yargesa : EPAR - Product Information HR = Hrvatski 2017-04-10  
Yargesa : EPAR - Product Information HR = Hrvatski 2017-04-10  
Yargesa : EPAR - Product Information HR = Hrvatski 2017-04-10  
Yargesa : EPAR - Product Information HR = Hrvatski 2017-04-10  
Yargesa : EPAR - Product Information HR = Hrvatski 2017-04-10  
Yargesa : EPAR - Product Information HR = Hrvatski 2017-04-10  

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
Yargesa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-10  
Yargesa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-10  
Yargesa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-10  
Yargesa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-10  
Yargesa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-10  
Yargesa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-10  
Yargesa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-10  
Yargesa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-10  
Yargesa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-10  
Yargesa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-10  
Yargesa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-10  
Yargesa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-10  
Yargesa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-10  
Yargesa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-10  
Yargesa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-10  
Yargesa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-10  
Yargesa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-10  
Yargesa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-10  
Yargesa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-10  
Yargesa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-10  
Yargesa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-10  
Yargesa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-10  
Yargesa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-10  
Yargesa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-10  
Yargesa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-10  

Pharmacotherapeutic group

Other alimentary tract and metabolism products

Therapeutic indication

Treatment of Gaucher disease.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Yargesa : EPAR - Public assessment report HR = Hrvatski 2017-04-10  
CHMP summary of positive opinion for Yargesa HR = Hrvatski 2017-01-27  

Authorised

This medicine is approved for use in the European Union

More information on Yargesa