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Register of orphan medicinal products


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Product information

Recombinant adeno-associated viral vector serotype 6 encoding the B-domain-deleted human factor VIII

EU orphan designation number: EU/3/17/1874   
Active ingredient: Recombinant adeno-associated viral vector serotype 6 encoding the B-domain-deleted human factor VIII
Indication: Treatment of haemophilia A
Sponsor: TxCell S.A.
Les Cardoulines Ht1, Allee De La Nertiere, 06560 Valbonne, France

   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
23/05/2017 Orphan designation EMA/OD/019/17 (2017)3607 of 22/05/2017
27/06/2018 Transfer of orphan designation EMA/OD/019/17/T/01 (2018)4099 of 25/06/2018
22/02/2019 Transfer of orphan designation EMA/OD/0000003577 (2019)1369 of 12/02/2019