EU/3/21/2397: Orphan designation for the treatment of uveal melanoma
Table of contents
This medicine was designated as an orphan medicine for the treatment of uveal melanoma in the European Union on 19 February 2021.
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.
During the medicine's development, doctors may be able to enrol patients in clinical trials investigating the medicine. For information on ongoing clinical trials in the EU, see:
Treatment of uveal melanoma
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Immunocore Ireland Limited
Review of designation
The Committee for Orphan Medicinal Products reviewed the orphan designation of Kimmtrak at the time of marketing authorisation, and confirmed that the orphan designation should be maintained.
More information is available in the orphan medicine assessment report .
The sponsorship was transferred to Immunocore Ireland Limited, in June 2021.
The sponsor’s address was updated in July 2021.
Sponsor Pharma Gateway AB applied for transfer to Immunocore Ireland Limited after receiving EC decision of orphan designation in Feb 2021
The medicinal product has been authorised in the EU as Kimmtrak since 1 April 2022.
Documents related to this orphan designation evaluation
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: