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.
Soliris : EPAR - Summary for the public (PDF/92.69 KB)
First published: 01/07/2009
Last updated: 25/08/2017
Soliris : EPAR - Risk-management-plan summary (PDF/126.92 KB)
First published: 04/09/2019
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Alexion Europe SAS
|Date of issue of marketing authorisation valid throughout the European Union||
26/08/2019 Soliris - EMEA/H/C/000791 - II/0105
- 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.
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.
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