MYOZYME

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

Active ingredients

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

1 Alglucosidase alfa UNII DTI67O9503 - ALGLUCOSIDASE ALFA

Alglucosidase alfa is an enzyme replacement therapy orphan drug for treatment of Pompe disease (Glycogen storage disease type II), a rare lysosomal storage disorder (LSD). It is postulated that alglucosidase alfa will restore lysosomal GAA activity resulting in stabilisation or restoration of cardiac and skeletal muscle function (including respiratory muscles). Due to the bloodbrain barrier effect and the enzyme’s size, uptake of alglucosidase alfa in the central nervous system is unlikely. Read about Alglucosidase alfa

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
Myozyme 50 mg, powder for concentrate for solution for infusion	Medicines & Healthcare Products Regulatory Agency (GB)	MPI, EU: SmPC
MYOZYME Powder for concentrate solution	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
A16AB07	Alglucosidase alfa	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 A16AB07

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): 576720050065717
Country: CA	Health Products and Food Branch	Identifier(s): 02284863
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 16-MBE-1214
Country: EE	Ravimiamet	Identifier(s): 1235764, 1235775, 1235786
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 06333001
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 043015
Country: FR	Base de données publique des médicaments	Identifier(s): 61065137
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 108979
Country: HK	Department of Health Drug Office	Identifier(s): 56437
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 6736
Country: IT	Agenzia del Farmaco	Identifier(s): 037174012, 037174024, 037174036
Country: JP	医薬品医療機器総合機構	Identifier(s): 3959412F1021
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1029921, 1029922, 1029923
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 80462
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 13292
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100164840
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W51536001, W51536002, W51536003
Country: SG	Health Sciences Authority	Identifier(s): 13543P
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699809260061, 8699809260078, 8699809260085
Country: ZA	Health Products Regulatory Authority	Identifier(s): 43/31/0745