EU/3/16/1633: Orphan designation for the treatment of gastro-entero-pancreatic neuroendocrine tumours

Fosbretabulin tromethamine


On 21 March 2016, orphan designation (EU/3/16/1633) was granted by the European Commission to Diamond BioPharm Limited, United Kingdom for fosbretabulin tromethamine for the treatment of gastro-entero-pancreatic neuroendocrine tumours.

The sponsorship was transferred to Diamond ROC EOOD, Bulgaria, in March 2019.

The sponsorship was transferred to Diamond Pharma Services Ireland Limited in February 2020.

Please note that this product was withdrawn from the Union Register of orphan medicinal products in September 2021 on request of the Sponsor.


Key facts

Active substance
Fosbretabulin tromethamine
Intented use
Treatment of gastro-entero-pancreatic neuroendocrine tumours
Orphan designation status
EU designation number
Date of designation

Diamond Pharma Services Ireland Limited 
Coliemore House
Coliemore Road
Co. Dublin
Tel. 02039119410

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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