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 18/01/2018

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
Orphan

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
23
Date of issue of marketing authorisation valid throughout the European Union
20/06/2007
Contact address
1-15 Avenue Edouard Belin
92500 Rueil-Malmaison
France

Product information

14/12/2017 Soliris - EMEA/H/C/000791 - II/98

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

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 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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