EU/3/13/1185
Table of contents
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.
The sponsor’s address was updated in November 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. More information is available in the
orphan medicine assessment report
.
Sponsor's contact details
Alexion Europe S.A.S.
103-105 Rue Anatole France
92300 Levallois Perret
France
E-mail: MedInfo@alexion.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.