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Community register of orphan medicinal products


GRANTED  

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: Swedish Orphan Biovitrum AB (publ)
SE-112 76 Stockholm, Sverige
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name ALPROLIX on 12/05/2016 with the number EU/1/16/1098

   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
12/06/2007 Orphan designation EMEA/OD/012/07 (2007)2559 of 08/06/2007
27/08/2010 Transfer of orphan designation EMEA/OD/012/07/T/01 (2010)5968 of 25/08/2010
28/09/2016 Transfer of orphan designation EMA/OD/012/07/T/02 (2016) 6303 of 26/09/2016