This is a summary of the European public assessment report (EPAR) for Aldurazyme. 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 Aldurazyme.
Aldurazyme : EPAR - Summary for the public (PDF/87.49 KB)
First published: 27/07/2009
Last updated: 11/02/2016
|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||
20/12/2018 Aldurazyme - EMEA/H/C/000477 - IG/1003
- 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
Aldurazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of mucopolysaccharidosis I (MPS I; alpha-L-iduronidase deficiency) to treat the nonneurological manifestations of the disease.