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Register of orphan medicinal products


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Adeno-associated viral vector serotype 8 containing a functional copy of the codon-optimised F8 cDNA encoding the B-domain deleted human coagulation factor VIII

EU orphan designation number: EU/3/18/2015   
Active ingredient: Adeno-associated viral vector serotype 8 containing a functional copy of the codon-optimised F8 cDNA encoding the B-domain deleted human coagulation factor VIII
Indication: Treatment of haemophilia A
Sponsor: Baxalta Innovations GmbH
Industriestraße 67, 1221 Wien, Österreich

  

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
29/05/2018 Orphan designation EMA/OD/010/18 (2018)3382 of 25/05/2018