EU/3/18/2050: Orphan designation for the treatment of neurofibromatosis type 1

Selumetinib

Overview

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. 

Key facts

Active substance
Selumetinib
Intented use
Treatment of neurofibromatosis type 1
Orphan designation status
Positive
EU designation number
EU/3/18/2050
Date of designation
31/07/2018
Sponsor

AstraZeneca AB
SE-151 85 Södertälje
Sweden
Tel. + 46 8 553 260 00
E-mail: orphandrugs@astrazeneca.com

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  PDF icon Koselugo - Orphan maintenance assessment report .

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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