EU/3/15/1472: Orphan designation for the diagnosis of glioma

Fluciclovine (18F)


On 24 April 2015, orphan designation (EU/3/15/1472) was granted by the European Commission to Blue Earth Diagnostics Ltd, United Kingdom, for fluciclovine (18F) for the diagnosis of glioma.

The sponsorship was transferred to to Blue Earth Diagnostics Ireland Limited, in November 2019

Key facts

Active substance
Fluciclovine (18F)
Intended use
Diagnosis of glioma
Orphan designation status
EU designation number
Date of designation

Blue Earth Diagnostics Ireland Limited
Floor 6
2 Grand Canal Square
Dublin 2
Co. Dublin

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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