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 07/06/2023

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
Sanofi B.V.
Revision
25
Date of issue of marketing authorisation valid throughout the European Union
28/03/2006
Contact address

Paasheuvelweg 25
1105 BP Amsterdam
Netherlands

Product information

14/04/2023 Myozyme - EMEA/H/C/000636 - II/0092

Other EU languages available icon 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.

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

Changes since initial authorisation of medicine

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