This medicine was designated as an orphan medicine for the treatment of uveal melanoma in the European Union on 13 April 2022.
This means that the developer will receive scientific and regulatory support from EMA to advance their medicine to the stage where they can apply for a marketing authorisation.
Orphan designation does not mean the medicine is available or authorised for use. All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
Treatment of uveal melanoma
|EU designation number||
|Date of designation||
|September 2023||The sponsorship was transferred from FGK Representative Service GmbH, Germany to Aura Biosciences B.V., Netherlands.|
Minutes of the COMP meeting on 15-17 March 2022 (PDF/505.22 KB)
First published: 13/06/2022
Last updated: 22/09/2022
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: