EU/3/00/002

About

Please note that this product was withdrawn from the Community register of designated orphan medicinal products in August 2011 at the end of the period of market exclusivity.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/3/00/002) 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.

Key facts

Active substance
Alpha-galactosidase A
Medicine name
Replagal
Disease / condition
Treatment of Fabry disease
Date of first decision
08/08/2000
Outcome
Expired
EU designation number
EU/3/00/002

Review of designation

Please note that this product (marketed as Replagal) was withdrawn from the Community register of designated orphan medicinal products in August 2011 at the end of the period of market exclusivity.

Sponsor's contact details

Shire Human Genetic Therapies AB
Rinkebyvägen 11B
182 36
Danderyd
Sweden
Tel. +46 8544 96400
Fax +46 8544 96429

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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