EU/3/18/2050: Orphan designation for the treatment of neurofibromatosis type 1
Table of contents
On 31 July 2018, orphan designation (EU/3/18/2050) was granted by the European Commission to AstraZeneca AB, Sweden, for selumetinib for the treatment of neurofibromatosis type 1.
The medicinal product has been authorised in the EU as Koselugo since date 17 June 2021.
Treatment of neurofibromatosis type 1
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Review of designation
The Committee for Orphan Medicinal Products reviewed the orphan designation of product at the time of marketing authorisation, and confirmed that the orphan designation should be maintained.
More information is available in the Koselugo - Orphan maintenance assessment report .
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: