EU/3/09/648: Orphan designation for the treatment of solar urticaria


Table of contents


On 24 July 2009, orphan designation (EU/3/09/648) was granted by the European Commission to Clinuvel UK Limited, United Kingdom, for afamelanotide for the treatment of solar urticaria.

The sponsorship was transferred to Clinuvel Europe Limited, Ireland, in March 2019

Key facts

Active substance
Intended use
Treatment of solar urticaria
Orphan designation status
EU designation number
Date of designation

Clinuvel Europe Limited
10 Earlsfort Terrace
Dublin 2 D02 T380
Tel:  +353 (0) 1513 4932

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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