Vimizim
elosulfase alfa
Table of contents
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.
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Vimizim : EPAR - Summary for the public (PDF/76.46 KB)
First published: 26/06/2014
Last updated: 26/06/2014
EMA/109796/2014 -
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Vimizim : EPAR - EMEA/H/C/002779 - Risk management plan summary (PDF/200.59 KB)
First published: 16/06/2021
Authorisation details
Product details | |
---|---|
Name |
Vimizim
|
Agency product number |
EMEA/H/C/002779
|
Active substance |
recombinant human n-acetylgalactosamine-6-sulfatase
|
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 | |
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Marketing-authorisation holder |
BioMarin International Limited
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Revision |
12
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Date of issue of marketing authorisation valid throughout the European Union |
27/04/2014
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Contact address |
Shanbally |
Product information
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.
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.