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 29/09/2017

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
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Genzyme Europe B.V.
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
29/03/2006
Contact address
Gooimer 10
NL-1411 DD Naarden
The Netherlands

Product information

08/09/2017 Myozyme - EMEA/H/C/000636 - N/0065

Contents

  • 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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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