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Register of orphan medicinal products


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Product information

Recombinant self-complementary adeno-associated viral vector serotype 9 containing the human CLN3 gene

EU orphan designation number: EU/3/16/1806   
Active ingredient: Recombinant self-complementary adeno-associated viral vector serotype 9 containing the human CLN3 gene
Indication: Treatment of neuronal ceroid lipofuscinosis
Sponsor: Abeona Therapeutics Europe SL
Calle Manoteras 30, A207-208, 28050 Madrid, España

   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
14/12/2016 Orphan designation EMA/OD/195/16 (2016)8706 of 12/12/2016
22/11/2017 Transfer of orphan designation EMA/OD/195/16/T/01 (2017)7864 of 20/11/2017