agalsidase beta

This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 29/05/2020

Authorisation details

Product details
Agency product number
Active substance
agalsidase beta
International non-proprietary name (INN) or common name
agalsidase beta
Therapeutic area (MeSH)
Fabry Disease
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Genzyme Europe B.V.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Paasheuvelweg 25
1105 BP Amsterdam
The Netherlands

Product information

17/04/2020 Fabrazyme - EMEA/H/C/000370 - II/0113


  • 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

Fabrazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (α-galactosidase-A deficiency).

Assessment history

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