EU/3/14/1355:

Selinexor

Overview

On 19 November 2014, orphan designation (EU/3/14/1355) was granted by the European Commission to Clinipace GmbH, Germany, for selinexor for the treatment of plasma cell myeloma.

The sponsorship was transferred to Karyopharm Europe GmbH, Germany, in August 2015.

Please note that this product (marketed as product name Nexpovio) was withdrawn from the Union Register of orphan medicinal products in February 2021 upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation.

Key facts

Active substance
Selinexor
Intented use
Treatment of plasma cell myeloma
Date of designation
19/11/2014
Orphan designation status
Positive
EU designation number
EU/3/14/1355

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of product at the time of marketing authorisation.

The sponsor formally requested the withdrawal of the orphan designation prior to the Committee’s final opinion. More information is available in the withdrawal assessment report – orphan maintenance.

Sponsor's contact details

Karyopharm Europe GmbH
Franziska-Bilek-Weg 9
80339 München
Germany
Tel. +49 8954 8486101
Fax +49 8954 8486200
http://karyopharm.com/contactus/

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.

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