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

Key facts

Active substance
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

Amryt Research Limited
90 Harcourt Street
Dublin D02 CR98
Tel: +353 86 8141007

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