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.
Vimizim : EPAR - Summary for the public (PDF/76.46 KB)
First published: 26/06/2014
Last updated: 26/06/2014
Vimizim : EPAR - EMEA/H/C/002779 - Risk management plan summary (PDF/200.59 KB)
First published: 16/06/2021
|Agency product number||
recombinant human n-acetylgalactosamine-6-sulfatase
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
BioMarin International Limited
|Date of issue of marketing authorisation valid throughout the European Union||
09/04/2021 Vimizim - EMEA/H/C/002779 - II/0034
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.
Other alimentary tract and metabolism products
Vimizim is indicated for the treatment of mucopolysaccharidosis, type IVA (Morquio A Syndrome, MPS IVA) in patients of all ages.