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 24/11/2021

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
Publication details
Marketing-authorisation holder
Genzyme Europe BV
Revision
22
Date of issue of marketing authorisation valid throughout the European Union
09/06/2003
Contact address

Paasheuvelweg 25
1105 BP Amsterdam
Netherlands

Product information

09/11/2021 Aldurazyme - EMEA/H/C/000477 - N/0081

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Select ‘available languages’ to access the language you need.

 

Product information documents contain:

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.

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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