On 8 August 2000, orphan designation (EU/3/00/003) was granted by the European Commission to Genzyme BV, the Netherlands, for alpha-galactosidase A for the treatment of Fabry disease.
Genzyme BV changed name to Genzyme Europe BV in 2002.
α-Galactosidase A has been authorised in the EU as Fabrazyme since 3 August 2001.
|Disease / condition||
Treatment of Fabry disease
|Date of first decision||
|EU designation number||
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.