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Adeno-associated viral vector serotype 8 containing the human UGT1A1 gene

EU orphan designation number: EU/3/16/1772   
Active ingredient: Adeno-associated viral vector serotype 8 containing the human UGT1A1 gene
Indication: Treatment of Crigler-Najjar syndrome
Sponsor: Audentes Therapeutics UK Limited
c/o Hackwood Secretaries Limited, One Silk Street, London EC2Y 8HQ, United Kingdom

   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
22/11/2016 Orphan designation EMA/OD/133/16 (2016)7614 of 18/11/2016