Myozyme

RSS

alglucosidase alfa

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 13/12/2021

Authorisation details

Product details
Name
Myozyme
Agency product number
EMEA/H/C/000636
Active substance
alglucosidase alfa
International non-proprietary name (INN) or common name
alglucosidase alfa
Therapeutic area (MeSH)
Glycogen Storage Disease Type II
Anatomical therapeutic chemical (ATC) code
A16AB07
Publication details
Marketing-authorisation holder
Genzyme Europe BV
Revision
19
Date of issue of marketing authorisation valid throughout the European Union
28/03/2006
Contact address

Paasheuvelweg 25
1105 BP Amsterdam
The Netherlands

Product information

08/12/2021 Myozyme - EMEA/H/C/000636 - N/0088

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.

Pharmacotherapeutic group

Other alimentary tract and metabolism products

Therapeutic indication

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.

Assessment history

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