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.
Myozyme : EPAR - Summary for the public (PDF/76.65 KB)
First published: 15/01/2009
Last updated: 23/01/2014
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Glycogen Storage Disease Type II
|Anatomical therapeutic chemical (ATC) code||
Genzyme Europe BV
|Date of issue of marketing authorisation valid throughout the European Union||
28/11/2019 Myozyme - EMEA/H/C/000636 - II/0075
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Other alimentary tract and metabolism products
Myozyme is indicated for long-term enzyme-replacement therapy (ERT) in patients with a confirmed diagnosis of Pompe disease (acid-α-glucosidase deficiency).
In patients with late-onset Pompe disease the evidence of efficacy is limited.