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 15/10/2018

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
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation

Publication details
Marketing-authorisation holder
Janssen Cilag International NV
Revision
28
Date of issue of marketing authorisation valid throughout the European Union
19/11/2002
Contact address

Turnhoutseweg 30
B 2340 Beerse
Belgium

Product information

27/09/2018 Zavesca - EMEA/H/C/000435 - T/0063

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.

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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