Idelvion

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albutrepenonacog alfa

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 09/02/2018

Authorisation details

Product details
Name
Idelvion
Agency product number
EMEA/H/C/003955
Active substance
albutrepenonacog alfa
International non-proprietary name (INN) or common name
albutrepenonacog alfa
Therapeutic area (MeSH)
Hemophilia B
Anatomical therapeutic chemical (ATC) code
B02BD04
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

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
CSL Behring GmbH
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
10/05/2016
Contact address
Emil-von-Behring-Straße 76
35041 Marburg
Germany

Product information

21/12/2017 Idelvion - EMEA/H/C/003955 - IB/0015

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

ANTIHEMORRHAGICS
 

Therapeutic indication

Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).

Assessment history

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