REPLAGAL

This brand name is authorized in Austria, Brazil, Canada, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Turkey, United Kingdom, South Africa

Active ingredients

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

1 Agalsidase alfa UNII 2HLC17MX9G - AGALSIDASE ALFA

Agalsidase alfa catalyses the hydrolysis of Gb3, cleaving a terminal galactose residue from the molecule. Treatment with the enzyme has been shown to reduce accumulation of Gb3 in many cell types including endothelial and parenchymal cells. Agalsidase alfa has been produced in a human cell line to provide for a human glycosylation profile that can influence uptake by mannose-6-phosphate receptors on the surface of target cells. Read about Agalsidase alfa

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
REPLAGAL Concentrate solution for infusion	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
A16AB03	Agalsidase alfa	A Alimentary tract and metabolism → A16 Other alimentary tract and metabolism products → A16A Other alimentary tract and metabolism products → A16AB Enzymes
Discover more medicines within A16AB03

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): 501121010034717
Country: CA	Health Products and Food Branch	Identifier(s): 02249057
Country: EE	Ravimiamet	Identifier(s): 1252943, 1252954, 1252965
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 01189001
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 007601
Country: FR	Base de données publique des médicaments	Identifier(s): 60397909
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 95445
Country: HK	Department of Health Drug Office	Identifier(s): 66873
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 6738
Country: IT	Agenzia del Farmaco	Identifier(s): 035373012
Country: JP	医薬品医療機器総合機構	Identifier(s): 3959410A1025
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1030661, 1030662, 1030663
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 99511
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 10005
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100114189
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W68716001, W68716002, W68716003
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699943790011
Country: ZA	Health Products Regulatory Authority	Identifier(s): 43/31/0309