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Pharmaceuticals - Community Register

  

Community list of not active orphan medicinal products


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Product information

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

EU orphan designation number: EU/3/10/783
Active ingredient: Recombinant fusion protein consisting of human coagulation factor VIII attached to the Fc domain of human IgG1
Indication: Treatment of haemophilia A
Sponsor: Biogen Idec Limited
Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Elocta on 19/11/2015 with the number EU/1/15/1046

   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
22/09/2010 Orphan designation EMA/OD/030/10 (2010)6650 of 20/09/2010
12/10/2015 Removal of orphan designation from Community Register