Table of contents
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
Idelvion : EPAR - Risk-mangement-plan summary (PDF/288.73 KB)
First published: 04/02/2021
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
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
|Date of issue of marketing authorisation valid throughout the European Union||
23/02/2023 Idelvion - EMEA/H/C/003955 - II/0059
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).