ELAPRASE

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

Active ingredients

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

1 Idursulfase UNII 5W8JGG2651 - IDURSULFASE

Idursulfase (idursulfase) is a purified form of the lysosomal enzyme iduronate-2-sulfatase, produced in a human cell line providing a human glycosylation profile, which is analogous to the naturally occurring enzyme. Elaprase is indicated for the long-term treatment of patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II). Read about Idursulfase

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
ELAPRASE 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
A16AB09	Idursulfase	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 A16AB09

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): 501121010034317
Country: CA	Health Products and Food Branch	Identifier(s): 02296314
Country: EE	Ravimiamet	Identifier(s): 1279964, 1279975, 1279986
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 06365001
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 085287
Country: FR	Base de données publique des médicaments	Identifier(s): 63288174
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 114913
Country: HK	Department of Health Drug Office	Identifier(s): 57104
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 6834
Country: JP	医薬品医療機器総合機構	Identifier(s): 3959413A1029
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1027962, 1027963, 1027964
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 130788
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 13423
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100042188
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W68717001, W68717002, W68717003
Country: SG	Health Sciences Authority	Identifier(s): 13902P
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699943790028
Country: US	FDA, National Drug Code	Identifier(s): 54092-700
Country: ZA	Health Products Regulatory Authority	Identifier(s): 45/31/0333