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||
06/10/2022 Myozyme - EMEA/H/C/000636 - II/0087
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.