EU/3/13/1185: Orphan designation for the treatment of neuromyelitis optica spectrum disorders

Eculizumab

Overview

On 24 April 2019, orphan designation (EU/3/13/1185) was granted by the European Commission to Alexion Europe S.A.S., France, for eculizumab for the treatment of neuromyelitis optica spectrum disorders.

Eculizumab for treatment of neuromyelitis optica spectrum disorders has been authorised in the EU as Soliris since 26 August 2019. 

The sponsor’s address was updated in November 2019.

Key facts

Active substance
Eculizumab
Intended use
Treatment of neuromyelitis optica spectrum disorders
Orphan designation status
Positive
EU designation number
EU/3/13/1185
Date of designation
05/08/2013
Sponsor

Alexion Europe S.A.S.
103-105 Rue Anatole France
92300 Levallois Perret
France
E-mail: MedInfo@alexion.com

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of Soliris at the time of marketing authorisation, and confirmed that the orphan designation should be maintained. More information is available in the PDF icon orphan medicine 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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