Aldurazyme
laronidase
Table of contents
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.
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 |
Sanofi B.V.
|
Revision |
24
|
Date of issue of marketing authorisation valid throughout the European Union |
09/06/2003
|
Contact address |
Paasheuvelweg 25 |
Product information
30/03/2023 Aldurazyme - EMEA/H/C/000477 - IB/0086
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.