ELAPRASE

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

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 more about Idursulfase

Medication package inserts

Below package inserts are available for further reading:

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