Galafold

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migalastat

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

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.

This EPAR was last updated on 12/05/2022

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 monitoringAdditional 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.

OrphanOrphan

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
Amicus Therapeutics Europe Limited
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
25/05/2016
Contact address

Amicus Therapeutics Europe Limited
Block 1, Blanchardstown Corporate Park
Ballycoolen Road
Blanchardstown, Dublin
D15 AKK1
Ireland

Product information

02/05/2022 Galafold - EMEA/H/C/004059 - IB/0037

Product information documents contain:

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

migalastat

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.

Assessment history

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