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Pharmaceuticals - Union Register

  

Register of orphan medicinal products


GRANTED  

Product information

Recombinant factor VIIa modified with three terminal repeats derived from the ß chain of human chorionic gonadotropin

EU orphan designation number: EU/3/14/1319   
Active ingredient: Recombinant factor VIIa modified with three terminal repeats derived from the ß chain of human chorionic gonadotropin
Indication: Treatment of haemophilia B
Sponsor: Richardson Associates Regulatory Affairs Ltd
22 Northumberland Road, Ballsbridge, Dublin 4 D04 ED73, Ireland

   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
26/08/2014 Orphan designation EMA/OD/073/14 (2014)6125 of 22/08/2014
19/12/2018 Transfer of orphan designation EMA/OD/0000002648 (2018)9010 of 14/12/2018