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).
Fabrazyme : EPAR - Summary for the public (PDF/75.52 KB)
First published: 10/04/2008
Last updated: 19/03/2013
Fabrazyme : EPAR - Risk-management-plan summary (PDF/151.18 KB)
First published: 29/05/2020
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Genzyme Europe BV
|Date of issue of marketing authorisation valid throughout the European Union||
19/05/2022 Fabrazyme - EMEA/H/C/000370 - II/0123
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
Fabrazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (α-galactosidase-A deficiency).
Supply shortages of Cerezyme and Fabrazyme - priority access for patients most in need of treatment recommended25/06/2009