Zavesca

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 Zavesca. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zavesca.

This EPAR was last updated on 15/01/2019

Authorisation details

Product details
Name
Zavesca
Agency product number
EMEA/H/C/000435
Active substance
miglustat
International non-proprietary name (INN) or common name
miglustat
Therapeutic area (MeSH)
  • Gaucher Disease
  • Niemann-Pick Diseases
Anatomical therapeutic chemical (ATC) code
A16AX06
Publication details
Marketing-authorisation holder
Janssen Cilag International NV
Revision
29
Date of issue of marketing authorisation valid throughout the European Union
20/11/2002
Contact address

Turnhoutseweg 30
B 2340 Beerse
Belgium

Product information

21/11/2018 Zavesca - EMEA/H/C/000435 - N/0064

Contents

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Pharmacotherapeutic group

Other alimentary tract and metabolism products

Therapeutic indication

Zavesca is indicated for the oral treatment of adult patients with mild to moderate type-1 Gaucher disease. Zavesca may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable.

Zavesca 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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