MYOZYME

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

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 more about Alglucosidase alfa

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
Myozyme 50 mg, powder for concentrate for solution for infusion	MPI, EU: SmPC	Medicines & Healthcare Products Regulatory Agency (GB)
MYOZYME Powder for concentrate solution	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
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)
BR	Câmara de Regulação do Mercado de Medicamentos	576720050065717
CA	Health Products and Food Branch	02284863
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	16-MBE-1214
EE	Ravimiamet	1235764, 1235775, 1235786
ES	Centro de información online de medicamentos de la AEMPS	06333001
FI	Lääkealan turvallisuus- ja kehittämiskeskus	043015
FR	Base de données publique des médicaments	61065137
GB	Medicines & Healthcare Products Regulatory Agency	108979
HK	Department of Health Drug Office	56437
IL	מִשְׂרַד הַבְּרִיאוּת	6736
IT	Agenzia del Farmaco	037174012, 037174024, 037174036
JP	医薬品医療機器総合機構	3959412F1021
LT	Valstybinė vaistų kontrolės tarnyba	1029921, 1029922, 1029923
NL	Z-Index G-Standaard, PRK	80462
NZ	Medicines and Medical Devices Safety Authority	13292
PL	Rejestru Produktów Leczniczych	100164840
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W51536001, W51536002, W51536003
SG	Health Sciences Authority	13543P
TR	İlaç ve Tıbbi Cihaz Kurumu	8699809260061, 8699809260078, 8699809260085
ZA	Health Products Regulatory Authority	43/31/0745