This is a summary of the European public assessment report (EPAR) for Myozyme. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Myozyme.
Therapeutic Indication
### Therapeutic indication Myozyme is indicated for long-term enzyme-replacement therapy (ERT) in patients with a confirmed diagnosis of Pompe disease (acid-?-glucosidase deficiency). In patients with late-onset Pompe disease the evidence of efficacy is limited.
Therapeutic Area (MeSH)
ATC Code
A16AB07
ATC Item
alglucosidase alfa
Pharmacotherapeutic Group
Other alimentary tract and metabolism products
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| alglucosidase alfa | N/A | 阿糖苷酶α |
EMA Name
Myozyme
Medicine Name
Myozyme
Aliases
N/ANo risk management plan link.
