Yargesa

RSS

miglustat

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

Overview

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.

This EPAR was last updated on 02/03/2022

Authorisation details

Product details
Name
Yargesa
Agency product number
EMEA/H/C/004016
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
Piramal Critical Care B.V.
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
22/03/2017
Contact address

Rouboslaan 32
2252 TR Voorschoten
Netehrlands

Product information

11/01/2022 Yargesa - EMEA/H/C/004016 - R/0011

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Other alimentary tract and metabolism products

Therapeutic indication

Yargesa is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease.

Yargesa may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable.

Yargesa 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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