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.
Following a corrigendum procedure, the active ingredient was renamed from dry extract from birch bark (DER 0.1-0.2:1), extraction solvent n-heptane 95% (V/V) to dry extract from birch bark (DER 5-10 : 1), extraction solvent n-heptane 95% (w/w) in March 2021.
This medicine is now known as birch bark extract.
The medicinal product has been authorised in the EU as Filsuvez since 21 June 2022.
dry extract from birch bark (DER 5-10 : 1), extraction solvent n-heptane 95% (w/w) (birch bark extract)
Treatment of epidermolysis bullosa
|Orphan designation status||
|EU designation number||
|Date of designation||
Review of designation
The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.
The Committee for Orphan Medicinal Products reviewed the orphan designation of Filsuvez at the time of marketing authorisation, and confirmed that the orphan designation should be maintained. More information is available in the orphan medicine assessment report.
|March 2021||The sponsorship was transferred to Amryt Pharmaceuticals Designated Activity Company, Ireland in March 2021.|
|October 2019||The sponsorship was transferred to Amryt Research Limited, Ireland, in October 2019.|
Documents related to this orphan designation evaluation
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
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.
EU register of orphan medicines
The list of medicines that have received an orphan designation in the EU is available on the European Commission's website: