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Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

Recombinant fusion protein linking human coagulation factor IX with human albumin

EU orphan designation number: EU/3/09/723   
Active ingredient: Recombinant fusion protein linking human coagulation factor IX with human albumin
Indication: Treatment of haemophilia B
Sponsor: CSL Behring GmbH
Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name IDELVION on 11/05/2016 with the number EU/1/16/1095

   Public summary of scientific opinion     EPAR

European Commission proceduresGoto top of the page
Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
08/02/2010 Orphan designation EMEA/OD/117/09 (2010)864 of 04/02/2010
30/09/2010 Corrigendum (2010)6817 of 28/09/2010