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.
Galafold : EPAR - Summary for the public (PDF/96.89 KB)
First published: 09/06/2016
Last updated: 09/06/2016
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Amicus Therapeutics Europe Limited
|Date of issue of marketing authorisation valid throughout the European Union||
28/03/2019 Galafold - EMEA/H/C/004059 - T/0020
- 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.
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.