EU/3/13/1185

About

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. 

Key facts

Active substance
Eculizumab
Disease / condition
Treatment of neuromyelitis optica spectrum disorders
Date of first decision
05/08/2013
Outcome
Positive
EU designation number
EU/3/13/1185

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. 

Sponsor's contact details

Alexion Europe S.A.S.
1-15, avenue Edouard Belin
92500 Rueil-Malmaison
France
Tel. +33 1 47 10 06 15
E-mail: medicalinformation.europe@alxn.com

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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