EU/3/01/078: Orphan designation for the treatment of mucopolysaccharidosis type II (Hunter's syndrome)
Iduronate-2-sulfatase
Table of contents
Overview
Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in January 2017 at the end of the period of market exclusivity.
On 11 December 2001, orphan designation (EU/3/01/078) was granted by the European Commission to TKT UK Limited, United Kingdom, for iduronate-2-sulfatase for the treatment of mucopolysaccharidosis, type II (Hunter Syndrome).
The sponsorship was transferred to TKT Europe AB, Sweden, in December 2005.
The sponsor changed its name to Shire Human Genetic Therapies AB in February 2010.
Iduronate-2-sulfatase has been authorised in the EU as Elaprase since 8 January 2007.
Key facts
Active substance |
Iduronate-2-sulfatase
|
Medicine name |
Elaprase
|
Intended use |
Treatment of mucopolysaccharidosis type II (Hunter's syndrome)
|
Orphan designation status |
Expired
|
EU designation number |
EU/3/01/078
|
Date of designation |
11/12/2001
|
Sponsor |
Shire Human Genetic Therapies AB
Svärdvägen 11D 182 33 Danderyd Sweden Tel. +46 8 5449 6400 Fax +46 8 5449 6429 |
Review of designation
Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in January 2017 at the end of the period of market exclusivity.
Patients' organisations
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.
EU register of orphan medicines
The list of medicines that have received an orphan designation in the EU is available on the European Commission's website: