Galafold
migalastat
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Galafold. 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 Galafold.
For practical information about using Galafold, patients should read the package leaflet or contact their doctor or pharmacist.
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Galafold : EPAR - Summary for the public (PDF/118.5 KB)
First published: 09/06/2016
Last updated: 27/08/2021 -
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Galafold : EPAR - Risk-management-plan summary (PDF/217.97 KB)
First published: 23/02/2021
Last updated: 25/02/2022
Authorisation details
Product details | |
---|---|
Name |
Galafold
|
Agency product number |
EMEA/H/C/004059
|
Active substance |
Migalastat hydrochloride
|
International non-proprietary name (INN) or common name |
migalastat
|
Therapeutic area (MeSH) |
Fabry Disease
|
Anatomical therapeutic chemical (ATC) code |
A16AX
|
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 |
Amicus Therapeutics Europe Limited
|
Revision |
16
|
Date of issue of marketing authorisation valid throughout the European Union |
25/05/2016
|
Contact address |
Amicus Therapeutics Europe Limited |
Product information
26/04/2023 Galafold - EMEA/H/C/004059 - II/0038
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
Therapeutic indication
Galafold is indicated for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency) and who have an amenable mutation.