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Pharmaceuticals - Union Register

  

Register of orphan medicinal products


GRANTED  

Product information

Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant

EU orphan designation number: EU/3/18/2080   
Active ingredient: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant
Indication: Treatment of haemophilia B
Sponsor: Freeline Therapeutics Ltd
Bioscience Catalyst, Gunnels Wood Road, Stevenage, Herts SG1 2FX, United Kingdom

  

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
30/10/2018 Orphan designation EMA/OD/127/18 (2018)7281 of 26/10/2018