This is a summary of the European public assessment report (EPAR) for Cerezyme. 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 Cerezyme.
Cerezyme : EPAR - Summary for the public (PDF/59.28 KB)
First published: 23/09/2009
Last updated: 06/10/2010
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Genzyme Europe B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
18/02/2020 Cerezyme - EMEA/H/C/000157 - IB/0117/G
- 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
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Other alimentary tract and metabolism products
Cerezyme (imiglucerase) is indicated for use as longterm enzyme replacement therapy in patients with a confirmed diagnosis of non-neuronopathic (Type 1) or chronic neuronopathic (Type 3) Gaucher disease who exhibit clinically significant nonneurological manifestations of the disease. The non-neurological manifestations of Gaucher disease include one or more of the following conditions:
- anaemia after exclusion of other causes, such as iron deficiency
- Bone disease after exclusion of other causes such as Vitamin D deficiency
- hepatomegaly or splenomegaly
Supply shortages of Cerezyme and Fabrazyme - priority access for patients most in need of treatment recommended25/06/2009