Please note that this product was withdrawn from the Union Register of orphan medicinal products in November 2020 on request of the Sponsor.

On 16 January 2014, orphan designation (EU/3/13/1232) was granted by the European Commission to ORS Oxford Ltd, United Kingdom, for allantoin for the treatment of epidermolysis bullosa.

The sponsorship was transferred as follows:
•    to Scioderm Limited, Ireland, in October 2014;
•    to Amicus Therapeutics UK Ltd, United Kingdom, February 2016;
•    and finally to Amicus Therapeutics Europe Limited, Ireland, in March 2019.

Key facts

Active substance
Disease / condition
Treatment of epidermolysis bullosa
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

Amicus Therapeutics Europe Limited
Block 1, Blanchardstown Corporate Park
Ballycoolen Road
Dublin D15 AKK1
Tel. +353 1 588 6850

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.

How useful was this page?

Add your rating