Soliris

RSS

eculizumab

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Soliris. It explains how the Agency assessed the medicine to recommend its authorisation and its conditions of use. It is not intended to provide practical advice on how to use Soliris.

For practical information about using Soliris, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 08/08/2019

Authorisation details

Product details
Name
Soliris
Agency product number
EMEA/H/C/000791
Active substance
Eculizumab
International non-proprietary name (INN) or common name
eculizumab
Therapeutic area (MeSH)
Hemoglobinuria, Paroxysmal
Anatomical therapeutic chemical (ATC) code
L04AA25
OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Alexion Europe SAS
Revision
25
Date of issue of marketing authorisation valid throughout the European Union
20/06/2007
Contact address

103-105 rue Anatole France
92300 Levallois-Perret
France

Product information

25/07/2019 Soliris - EMEA/H/C/000791 - IAIN/0106

Contents

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Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Soliris is indicated in adults and children for the treatment of patients with paroxysmal nocturnal haemoglobinuria (PNH). Evidence of clinical benefit demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history.

Assessment history

Changes since initial authorisation of medicine

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