ALDURAZYME

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

Active ingredients

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

1 Laronidase UNII WP58SVM6R4 - LARONIDASE

Laronidase is a recombinant form of human α-L-iduronidase and is produced by recombinant DNA technology. Laronidase is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Mucopolysaccharidosis I (MPS I; α-L-iduronidase deficiency) to treat the non-neurological manifestations of the disease. Read about Laronidase

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
ALDURAZYME 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
A16AB05	Laronidase	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 A16AB05

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): 576720040061117
Country: CA	Health Products and Food Branch	Identifier(s): 02254506
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 5-MBE-0314
Country: EE	Ravimiamet	Identifier(s): 1201565, 1201576, 1201587
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 03253001
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 014439
Country: FR	Base de données publique des médicaments	Identifier(s): 66328396
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 46582
Country: HK	Department of Health Drug Office	Identifier(s): 56438
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 7126
Country: JP	医薬品医療機器総合機構	Identifier(s): 3959411A1020
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1027352, 1027353, 1027354
Country: NL	Z-Index G-Standaard	Identifier(s): 14969467
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 75175
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 18303
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100126519
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W42203001, W42203002, W42203003
Country: SG	Health Sciences Authority	Identifier(s): 13347P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 3843021H
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699809779150
Country: US	FDA, National Drug Code	Identifier(s): 58468-0070
Country: ZA	Health Products Regulatory Authority	Identifier(s): 44/31/0500