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Community register of orphan medicinal products


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Product information

Recombinant fusion protein consisting of human coagulation factor IX attached to the Fc domain of human IgG1

EU orphan designation number: EU/3/07/453   
Active ingredient: Recombinant fusion protein consisting of human coagulation factor IX attached to the Fc domain of human IgG1
Indication: Treatment of haemophilia B (congenital factor IX deficiency)
Sponsor: Biogen Idec Limited
Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom

   Public summary of scientific opinion    

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
12/06/2007 Centralised Orphan - Designation EMEA/OD/012/07 (2007)2559 of 08/06/2007
27/08/2010 Centralised Orphan - Transfer of orphan designation EMEA/OD/012/07/T/01 (2010)5968 of 25/08/2010