EU/3/20/2391: Orphan designation for the treatment of mucopolysaccharidosis type II (Hunter's syndrome)
Table of contents
On 6 January 2021, orphan designation EU/3/20/2391 was granted by the European Commission to Shire Pharmaceuticals Ireland Limited, Ireland, for idursulfase for the treatment of mucopolysaccharidosis type II (Hunter's syndrome).
The sponsorship was transferred to Takeda Pharmaceuticals International AG Ireland Branch, Ireland, in October 2021.
Treatment of mucopolysaccharidosis type II (Hunter's syndrome)
|Orphan designation status||
|EU designation number||
|Date of designation||
Takeda Pharmaceuticals International AG Ireland Branch
Review of designation
The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.
|January 2023||Please note that this product was withdrawn from the Union Register of orphan medicinal products on request of the Sponsor.|
|October 2022||The sponsor's address was updated in October 2022.|
Documents related to this orphan designation evaluation
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: