NAGLAZYME

This brand name is authorized in United States. It is also authorized in Austria, Brazil, Canada, Croatia, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Spain, UK.

Active ingredients

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

1	Galsulfase UNII 59UA429E5G - GALSULFASE
	Purified galsulfase, a recombinant form of human N-acetylgalactosamine 4-sulfatase, is a glycoprotein with a molecular weight of approximately 56 kD. Galsulfase is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Mucopolysaccharidosis VI (MPS VI; N-acetylgalactosamine 4-sulfatase deficiency; Maroteaux-Lamy syndrome).
	Read more about Galsulfase

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
NAGLAZYME Concentrate for 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
A16AB08	Galsulfase	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 A16AB08

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	542413080000002
CA	Health Products and Food Branch	02412683
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	H7030913
EE	Ravimiamet	1245743, 1489068
ES	Centro de información online de medicamentos de la AEMPS	05324001
FI	Lääkealan turvallisuus- ja kehittämiskeskus	064596
FR	Base de données publique des médicaments	66966299
GB	Medicines & Healthcare Products Regulatory Agency	100931
HK	Department of Health Drug Office	59924
IL	מִשְׂרַד הַבְּרִיאוּת	7081
IT	Agenzia del Farmaco	037173010
JP	医薬品医療機器総合機構	3959414A1023
LT	Valstybinė vaistų kontrolės tarnyba	1029470, 1050850
NZ	Medicines and Medical Devices Safety Authority	17616
PL	Rejestru Produktów Leczniczych	100162716
US	FDA, National Drug Code	68135-020