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
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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.
Alexion Europe SAS
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14/12/2017 Soliris - EMEA/H/C/000791 - II/98
- 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 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.
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