This is a summary of the European public assessment report (EPAR) for Idelvion. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Idelvion.
For practical information about using Idelvion, patients should read the package leaflet or contact their doctor or pharmacist.
Idelvion : EPAR - Summary for the public (PDF/76.87 KB)
First published: 27/05/2016
Last updated: 27/05/2016
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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.
CSL Behring GmbH
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21/12/2017 Idelvion - EMEA/H/C/003955 - IB/0015
- 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
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Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).