GALAFOLD

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

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 about Migalastat

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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