On 26 November 2010, orphan designation (EU/3/10/813) was granted by the European Commission to Shire Pharmaceuticals Ireland Limited, Ireland, for recombinant human arylsulfatase A for the treatment of metachromatic leukodystrophy.
Recombinant human arylsulfatase A
|Disease / condition||
treatment of metachromatic leukodystrophy
|Date of first decision||
|EU designation number||
Review of designation
The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.
Sponsor's contact details
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
- Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;
- European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.