Cerezyme

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imiglucerase

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 16/03/2020

Authorisation details

Product details
Name
Cerezyme
Agency product number
EMEA/H/C/000157
Active substance
imiglucerase
International non-proprietary name (INN) or common name
imiglucerase
Therapeutic area (MeSH)
Gaucher Disease
Anatomical therapeutic chemical (ATC) code
A16AB02
Publication details
Marketing-authorisation holder
Genzyme Europe B.V.
Revision
24
Date of issue of marketing authorisation valid throughout the European Union
17/11/1997
Contact address

Paasheuvelweg 25
1105 BP Amsterdam
The Netherlands

Product information

18/02/2020 Cerezyme - EMEA/H/C/000157 - IB/0117/G

Contents

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Pharmacotherapeutic group

Other alimentary tract and metabolism products

Therapeutic indication

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
  • Thrombocytopenia
  • Bone disease after exclusion of other causes such as Vitamin D deficiency
  • hepatomegaly or splenomegaly

Assessment history

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