EU/3/09/637: Orphan designation for the treatment of 5-fluorouracil overdose


Table of contents


On 15 May 2009, orphan designation (EU/3/09/637) was granted by the European Commission to Wellstat Therapeutics EU Limited, United Kingdom, for 2',3',5'-tri-O-acetyluridine for the treatment of 5-fluorouracil overdose.

The sponsorship was transferred to Wellstat Therapeutics EU Limited, Ireland, in February 2021.

Key facts

Active substance
Intended use
Treatment of 5-fluorouracil overdose
Orphan designation status
EU designation number
Date of designation

Wellstat Therapeutics EU Limited
8th Floor
South Bank House
Barrow Street
Dublin 4 D04 TR29

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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