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Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in August 2011 at the end of the period of market exclusivity.

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.

Key facts

Active substance
Alpha-galactosidase A
Medicine name
Disease / condition
Treatment of Fabry disease
Date of first decision
EU designation number

Sponsor's contact details

Genzyme Europe BV
Gooimeer 10
1411 DD Naarden
The Netherlands
Tel. +31 35 699 1200
Fax +31 35 694 3214

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.

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