EU/3/10/754: Orphan designation for the treatment of traumatic spinal cord injury

Heparin-activated recombinant human fibroblast growth factor 1 (on a biodegradable device made from alpha-calcium sulfate hemihydrate)

Table of contents

Overview

Please note that this product was withdrawn from the Union Register of orphan medicinal products in January 2021 on request of the sponsor.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.

Key facts

Active substance
Heparin-activated recombinant human fibroblast growth factor 1 (on a biodegradable device made from alpha-calcium sulfate hemihydrate)
Intended use
Treatment of traumatic spinal cord injury
Orphan designation status
Withdrawn
EU designation number
EU/3/10/754
Date of designation
27/07/2010
Sponsor
BioArctic AB
Warfvinges väg 35
SE-112 51 Stockholm
Sweden
Tel. + 46 7 34411798
E-mail: gillian@albanyregulatory.co.uk

Documents related to this orphan designation evaluation

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.

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:

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