Miglustat Gen.Orph

miglustat

  • Email
  • Help

About

This is a summary of the European public assessment report (EPAR) for Miglustat Gen.Orph. 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 Miglustat Gen.Orph.

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

What is Miglustat Gen.Orph and what is it used for?

Miglustat Gen.Orph 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. Miglustat Gen.Orph is used in patients who cannot receive enzyme-replacement therapy.

Miglustat Gen.Orph 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 Miglustat Gen.Orph used?

Miglustat Gen.Orph 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. For more information, see the package leaflet.

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.

How does Miglustat Gen.Orph work?

The active substance in Miglustat Gen.Orph, 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 Miglustat Gen.Orph 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 Miglustat Gen.Orph.

As for every medicine, the company provided studies on the quality of Miglustat Gen.Orph. 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 Miglustat Gen.Orph?

Because Miglustat Gen.Orph 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 Miglustat Gen.Orph approved?

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

What measures are being taken to ensure the safe and effective use of Miglustat Gen.Orph?

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

Other information about Miglustat Gen.Orph

The European Commission granted a marketing authorisation valid throughout the European Union for Miglustat Gen.Orph on 10 November 2017.

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

Name Language First published Last updated
Miglustat Gen.Orph : EPAR - Summary for the public BG = bălgarski 2017-11-23  
Miglustat Gen.Orph : EPAR - Summary for the public ES = español 2017-11-23  
Miglustat Gen.Orph : EPAR - Summary for the public CS = čeština 2017-11-23  
Miglustat Gen.Orph : EPAR - Summary for the public DA = dansk 2017-11-23  
Miglustat Gen.Orph : EPAR - Summary for the public DE = Deutsch 2017-11-23  
Miglustat Gen.Orph : EPAR - Summary for the public ET = eesti keel 2017-11-23  
Miglustat Gen.Orph : EPAR - Summary for the public EL = elliniká 2017-11-23  
Miglustat Gen.Orph : EPAR - Summary for the public EN = English 2017-11-23  
Miglustat Gen.Orph : EPAR - Summary for the public FR = français 2017-11-23  
Miglustat Gen.Orph : EPAR - Summary for the public IT = italiano 2017-11-23  
Miglustat Gen.Orph : EPAR - Summary for the public LV = latviešu valoda 2017-11-23  
Miglustat Gen.Orph : EPAR - Summary for the public LT = lietuvių kalba 2017-11-23  
Miglustat Gen.Orph : EPAR - Summary for the public HU = magyar 2017-11-23  
Miglustat Gen.Orph : EPAR - Summary for the public MT = Malti 2017-11-23  
Miglustat Gen.Orph : EPAR - Summary for the public NL = Nederlands 2017-11-23  
Miglustat Gen.Orph : EPAR - Summary for the public PL = polski 2017-11-23  
Miglustat Gen.Orph : EPAR - Summary for the public PT = português 2017-11-23  
Miglustat Gen.Orph : EPAR - Summary for the public RO = română 2017-11-23  
Miglustat Gen.Orph : EPAR - Summary for the public SK = slovenčina 2017-11-23  
Miglustat Gen.Orph : EPAR - Summary for the public SL = slovenščina 2017-11-23  
Miglustat Gen.Orph : EPAR - Summary for the public FI = suomi 2017-11-23  
Miglustat Gen.Orph : EPAR - Summary for the public SV = svenska 2017-11-23  
Miglustat Gen.Orph : EPAR - Summary for the public HR = Hrvatski 2017-11-23  
Miglustat Gen.Orph : EPAR - Summary for the public IS = Islenska 2017-11-23  
Miglustat Gen.Orph : EPAR - Summary for the public NO = Norsk 2017-11-23  

This EPAR was last updated on 23/11/2017 .

Authorisation details

Product details

Product details for Miglustat Gen.Orph
NameMiglustat Gen.Orph
Agency product numberEMEA/H/C/004366
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 Miglustat Gen.Orph
Marketing-authorisation holder

Gen.Orph

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

Contact address:

Gen.Orph
100 Rue Louis Blanc
TSA / Batiment Copenhague
60160 Montataire
France

Product information

Product information

10/11/2017  Miglustat Gen.Orph -EMEA/H/C/004366 --

Name Language First published Last updated
Miglustat Gen.Orph : EPAR - Product Information NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - Product Information NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - Product Information NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - Product Information NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - Product Information NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - Product Information NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - Product Information NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - Product Information NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - Product Information NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - Product Information NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - Product Information NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - Product Information NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - Product Information NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - Product Information NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - Product Information NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - Product Information NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - Product Information NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - Product Information NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - Product Information NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - Product Information NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - Product Information NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - Product Information NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - Product Information NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - Product Information NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - Product Information NO = Norsk 2017-11-23  

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
Miglustat Gen.Orph : EPAR - All Authorised presentations NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - All Authorised presentations NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - All Authorised presentations NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - All Authorised presentations NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - All Authorised presentations NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - All Authorised presentations NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - All Authorised presentations NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - All Authorised presentations NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - All Authorised presentations NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - All Authorised presentations NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - All Authorised presentations NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - All Authorised presentations NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - All Authorised presentations NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - All Authorised presentations NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - All Authorised presentations NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - All Authorised presentations NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - All Authorised presentations NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - All Authorised presentations NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - All Authorised presentations NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - All Authorised presentations NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - All Authorised presentations NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - All Authorised presentations NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - All Authorised presentations NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - All Authorised presentations NO = Norsk 2017-11-23  
Miglustat Gen.Orph : EPAR - All Authorised presentations NO = Norsk 2017-11-23  

Pharmacotherapeutic group

Other alimentary tract and metabolism products

Therapeutic indication

Miglustat Gen.Orph is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease. Miglustat Gen.Orph may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable (see sections 4.4 and 5.1).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Miglustat Gen.Orph : EPAR - Public assessment report NO = Norsk 2017-11-23  
CHMP summary of positive opinion for Miglustat Gen.Orph NO = Norsk 2017-09-15  

Authorised

This medicine is approved for use in the European Union

More information on Miglustat GenOrph