NAGLAZYME

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

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 about Galsulfase

Medication package inserts

Below package inserts are available for further reading:

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