Basic Information
Myozyme
Regulatory Information
EMEA/H/C/000636
Authorised
March 28, 2006
31
August 16, 2024
Company Information
Netherlands
Paasheuvelweg 25 1105 BP Amsterdam
Sanofi B.V.
Active Substances Detail
EMA Resources
Detailed Information
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.
Overview Summary
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.