EU/3/15/1535: Orphan designation for the treatment of acute radiation syndrome

Fibrinogen-coated albumin spheres


On 10 August 2015, orphan designation (EU/3/15/1535) was granted by the European Commission to Fibreu Limited, United kingdom, for fibrinogen-coated albumin spheres for the treatment of acute radiation syndrome.

The sponsorship was transferred to Fibreu Limitless Research S.L., Spain, in May 2019.

Key facts

Active substance
Fibrinogen-coated albumin spheres
Intended use
Treatment of acute radiation syndrome
Orphan designation status
EU designation number
Date of designation

Fibreu Limitless Research S.L.
Calle Lopez De Neira Num. 3
Planta 3 Puerta 301
Pontevedra 36202
Tel. +34 722 822 251

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

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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