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
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 Powder for concentrate solution MPI, EU: SmPC European Medicines Agency (EU)
 Myozyme 50 mg, powder for concentrate for solution for infusion MPI, EU: SmPC Medicines & Healthcare Products Regulatory Agency (GB)

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

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