Aldurazyme

RSS

laronidase

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

Overview

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.

This EPAR was last updated on 08/11/2018

Authorisation details

Product details
Name
Aldurazyme
Agency product number
EMEA/H/C/000477
Active substance
laronidase
International non-proprietary name (INN) or common name
laronidase
Therapeutic area (MeSH)
Mucopolysaccharidosis I
Anatomical therapeutic chemical (ATC) code
A16AB05
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Genzyme Europe B.V.
Revision
17
Date of issue of marketing authorisation valid throughout the European Union
09/06/2003
Contact address
Gooimer 10
NL-1411 DD Naarden
The Netherlands

Product information

08/10/2018 Aldurazyme - EMEA/H/C/000477 - IAIN/0070

Contents

  • 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

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.

Assessment history

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