Miglustat Gen.Orph

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miglustat

Authorised
This medicine is authorised for use in the European Union.

Overview

Miglustat Gen.Orph is used to treat two inherited diseases that affect the way the body handles fats. Both diseases cause a build-up of fatty substances called glycosphingolipids in the body. Miglustat Gen.Orph is used to treat the following patients:

adults (aged 18 years and above) with mild to moderate type-1 Gaucher disease. Patients with this disease lack an enzyme called glucocerebrosidase, which results in a glycosphingolipid called glucosylceramide building up in different parts of the body, such as the spleen, liver and bones. Miglustat Gen.Orph is used in patients who cannot receive the standard treatment of enzyme-replacement therapy (ERT);

patients of all ages with Niemann-Pick type-C disease, a potentially fatal disease in which glycosphingolipids build up within cells in the brain and elsewhere in the body. Miglustat Gen.Orph is used to treat the neurological symptoms of the disease (symptoms affecting the brain and nerves). These include loss of coordination, problems with ‘saccadic’ (rapid) eye movements that can lead to impaired vision, delayed development, difficulty swallowing, decreased muscle tone, fits and learning difficulties.

Miglustat Gen.Orph is a ‘generic medicine’. This means that Miglustat Gen.Orph contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Zavesca.

This EPAR was last updated on 08/07/2019

Authorisation details

Product details
Name
Miglustat Gen.Orph
Agency product number
EMEA/H/C/004366
Active substance
miglustat
International non-proprietary name (INN) or common name
miglustat
Therapeutic area (MeSH)
Gaucher Disease
Anatomical therapeutic chemical (ATC) code
A16AX06
GenericGeneric

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
Marketing-authorisation holder
Gen.Orph
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
09/11/2017
Contact address
185 Bureaux de la Colline
92213 Saint Cloud Cedex
France

Product information

22/05/2019 Miglustat Gen.Orph - EMEA/H/C/004366 - IB/0006

Contents

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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.

Miglustat Gen.Orph is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type C disease.

Assessment history

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