GALAFOLD

This brand name is authorized in United States. It is also authorized in Austria, Brazil, Canada, Croatia, Estonia, Finland, France, Ireland, Israel, Japan, Lithuania, Poland, Romania, Spain, Turkey, UK.

Active ingredients

The drug GALAFOLD contains one active pharmaceutical ingredient (API):

1	Migalastat UNII CLY7M0XD20 - MIGALASTAT HYDROCHLORIDE
	Migalastat is a pharmacological chaperone that is designed to selectively and reversibly bind with high affinity to the active sites of certain mutant forms of α-Gal A, the genotypes of which are referred to as amenable mutations. Migalastat binding stabilizes these mutant forms of α-Gal A in the endoplasmic reticulum and facilitates their proper trafficking to lysosomes.
	Read more about Migalastat

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
GALAFOLD Hard capsule	MPI, EU: SmPC	European Medicines Agency (EU)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
A16AX14		A Alimentary tract and metabolism → A16 Other alimentary tract and metabolism products → A16A Other alimentary tract and metabolism products → A16AX Various alimentary tract and metabolism products
Discover more medicines within A16AX14

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
BR	Câmara de Regulação do Mercado de Medicamentos	576121060000417
CA	Health Products and Food Branch	02468042
EE	Ravimiamet	1722013
ES	Centro de información online de medicamentos de la AEMPS	1151082001
FI	Lääkealan turvallisuus- ja kehittämiskeskus	434967
FR	Base de données publique des médicaments	62876801
GB	Medicines & Healthcare Products Regulatory Agency	346159
IE	Health Products Regulatory Authority	88870
IL	מִשְׂרַד הַבְּרִיאוּת	7981
JP	医薬品医療機器総合機構	3999045M1028
LT	Valstybinė vaistų kontrolės tarnyba	1080462
PL	Rejestru Produktów Leczniczych	100373287
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W65913001
TR	İlaç ve Tıbbi Cihaz Kurumu	8699783150624
US	FDA, National Drug Code	71904-100