On 8 August 2000, orphan designation (EU/3/00/002) was granted by the European Commission to TKT Europe-5S AB, Sweden, for alpha-galactosidase A for the treatment of Fabry disease.
The sponsor applied for a change of name to Shire Human Genetic Therapies AB in September 2010.
α-Galactosidase A has been authorised in the EU as Replagal since 3 August 2001.
|Disease / condition||
Treatment of Fabry disease
|Date of first decision||
|EU designation number||
Review of designation
Sponsor's contact details
Tel. +46 8544 96400
Fax +46 8544 96429
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.