REPLAGAL

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

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 more about Agalsidase alfa

Medication package inserts

Below package inserts are available for further reading:

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