Please note that this product was withdrawn from the Union Register of orphan medicinal products in January 2021 on request of the sponsor.
On 27 July 2010, orphan designation (EU/3/10/754) was granted by the European Commission to Bioarctic Neuroscience AB, Sweden, for heparin-activated recombinant human fibroblast growth factor 1 (on a biodegradable device made from alpha-calcium sulphate hemihydrate) for the treatment of traumatic spinal cord injury.
In September 2016, Bioarctic Neuroscience AB changed name to BioArctic AB.
Heparin-activated recombinant human fibroblast growth factor 1 (on a biodegradable device made from alpha-calcium sulfate hemihydrate)
Treatment of traumatic spinal cord injury
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Documents related to this orphan designation evaluation
EU/3/10/754: Public summary of opinion on orphan designation: Heparin-activated recombinant human fibroblast growth factor 1 (on a biodegradable device ade from alpha-calcium sulphate hemihydrate) for the treatment of tr... (PDF/232.66 KB)
First published: 05/08/2010
Last updated: 03/02/2021
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: