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Register of orphan medicinal products


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Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene

EU orphan designation number: EU/3/15/1518   
Active ingredient: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene
Indication: Treatment of inherited retinal dystrophies (initially named treatment of retinitis pigmentosa)
Sponsor: Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4 D04 A9N6, Ireland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Luxturna on 22/11/2018 with the number EU/1/18/1331

   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
30/07/2015 Orphan designation EMA/OD/040/15 (2015)5424 of 28/07/2015
13/03/2017 Transfer of orphan designation EMA/OD/040/15/T/01 (2017) 1707 of 9/03/2017
11/10/2018 Other procedure
25/02/2019 Transfer of orphan designation EMA/OD/0000003549 (2019)1628 of 21/02/2019