On 23 February 2011, orphan designation (EU/3/10/845) was granted by the European Commission to Birken GmbH, Germany, for dry extract from birch bark (DER 0.1-0.2:1), extraction solvent n-heptane 95% (V/V) for the treatment of epidermolysis bullosa.
The sponsorship was transferred to Amryt Research Limited, Ireland, in October 2019
EU/3/10/845: Public summary of opinion on orphan designation: Dry extract from Birch bark (DER 0.1-0.2:1), extraction solvent n-heptane 95% (V/V) for the treatment of epidermolysis bullosa (PDF/125.53 KB)
First published: 04/03/2011
Last updated: 28/06/2012
Dry extract from birch bark (DER 0.1-0.2:1), extraction solvent n-heptane 95% (V/V)
|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
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.