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.
Therapeutic Indication
### 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 (?-galactosidase A deficiency) and who have an amenable mutation.
Therapeutic Area (MeSH)
N/AATC Code
A16AX
ATC Item
各种消化道产物及代谢产物
Pharmacotherapeutic Group
migalastat
Active Substance (Summary)
INN / Common Names
N/A| Substance | CAS | Monograph |
|---|---|---|
| migalastat hydrochloride | N/A | Migalastat |
| Migalastat hydrochloride | N/A | Migalastat |
EMA Name
Galafold
Medicine Name
Galafold
Aliases
N/ANo risk management plan link.
