On 26 April 2012, orphan designation (EU/3/12/988) was granted by the European Commission to Biological Consulting Europe Ltd, United Kingdom, for the treatment of Duchenne muscular dystrophy.

Please note that this product was withdrawn from the Community Register of designated Orphan Medicinal Products in February 2019 on request of the Sponsor.

Key facts

Active substance
Halofuginone hydrobromide
Disease / condition
Treatment of Duchenne muscular dystrophy
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

Biological Consulting Europe Ltd
15 Station Road, Unit 1
St Monans
Fife KY10 2BL
United Kingdom
Tel. +44 (0)1333 730 170

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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