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 04/09/2019

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
Accelerated assessmentAccelerated assessment

This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

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
26
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

26/08/2019 Soliris - EMEA/H/C/000791 - II/0105

Contents

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You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Soliris is indicated in adults and children for the treatment of:

  • Paroxysmal nocturnal haemoglobinuria (PNH).

Evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history (see section 5.1).

  •  Atypical haemolytic uremic syndrome (aHUS).

Soliris is indicated in adults for the treatment of:

  • Refractory generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AChR) antibody-positive (see section 5.1).
  • Neuromyelitis optica spectrum disorder (NMOSD) in patients who are anti-aquaporin-4 (AQP4) antibody-positive with a relapsing course of the disease.

Assessment history

Changes since initial authorisation of medicine

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