CEREZYME

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 CEREZYME contains one active pharmaceutical ingredient (API):

1 Imiglucerase UNII Q6U6J48BWY - IMIGLUCERASE

Imiglucerase is a recombinant macrophage targeted acid β-glucosidase that replaces the deficient enzyme activity, hydrolysing glucosylceramide, thus correcting initial pathophysiology and preventing secondary pathology. Imiglucerase has been shown to improve both mental and physical aspects in the quality of life of Gaucher disease. Read about Imiglucerase

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
CEREZYME Powder for 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
A16AB02	Imiglucerase	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 A16AB02

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): 502818100077817, 576720040062117
Country: CA	Health Products and Food Branch	Identifier(s): 02241751
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): H7781013
Country: EE	Ravimiamet	Identifier(s): 1129867, 1129878, 1129889, 1129890, 1129902
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 97053003
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 465609
Country: FR	Base de données publique des médicaments	Identifier(s): 62616337
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 48780
Country: HK	Department of Health Drug Office	Identifier(s): 60392
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 6459
Country: JP	医薬品医療機器総合機構	Identifier(s): 3959406D2021
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1007025, 1007026, 1028071, 1028072, 1028073
Country: NL	Z-Index G-Standaard	Identifier(s): 14624273
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 58319
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 14478
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100097730, 100212710
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W08253001, W08253002, W08253003
Country: SG	Health Sciences Authority	Identifier(s): 13842P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 3843031H
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699809260047
Country: US	FDA, National Drug Code	Identifier(s): 58468-1983, 58468-4663
Country: ZA	Health Products Regulatory Authority	Identifier(s): 36/31/0179