Vimizim

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elosulfase alfa

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

Overview

This is a summary of the European public assessment report (EPAR) for Vimizim. 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 Vimizim.

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

This EPAR was last updated on 08/11/2018

Authorisation details

Product details
Name
Vimizim
Agency product number
EMEA/H/C/002779
Active substance
recombinant human n-acetylgalactosamine-6-sulfatase (rhgalns)
International non-proprietary name (INN) or common name
elosulfase alfa
Therapeutic area (MeSH)
Mucopolysaccharidosis IV
Anatomical therapeutic chemical (ATC) code
A16AB12
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

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
BioMarin International Limited
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
27/04/2014
Contact address

Shanbally, Ringaskiddy
County Cork, P43 R298
Ireland

Product information

28/09/2018 Vimizim - EMEA/H/C/002779 - T/0026

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

Vimizim is indicated for the treatment of mucopolysaccharidosis, type IVA (Morquio A Syndrome, MPS IVA) in patients of all ages.

Assessment history

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