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Community register of orphan medicinal products


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Product information

Adeno-associated viral vector containing the human NADH dehydrogenase 4 gene

EU orphan designation number: EU/3/11/860   
Active ingredient: Adeno-associated viral vector containing the human NADH dehydrogenase 4 gene
Indication: Treatment of Leber's hereditary optic neuropathy
Sponsor: GenSight- Biologics
74 rue du Faubourg Saint-Antoine, 75012 Paris, 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
18/05/2011 Orphan designation EMA/OD/164/10 (2011)3486 of 13/05/2011
26/09/2013 Transfer of orphan designation EMA/OD/164/10/T/01 (2013)6304 of 24/09/2013
23/10/2015 Change of name and/or address of sponsor