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Community register of orphan medicinal products


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Product information

Adenovirus associated viral vector serotype 2 containing the human RPE65 gene

EU orphan designation number: EU/3/12/981   
Active ingredient: Adenovirus associated viral vector serotype 2 containing the human RPE65 gene
Indication: Treatment of Leber’s congenital amaurosis
Sponsor: Spark Therapeutics Ireland Ltd
The Tower, Trinity Technology & Enterprise Campus, Pearse Street, Dublin 2, Ireland

   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
04/04/2012 Orphan designation EMA/OD/150/11 (2012)2351 of 02/04/2012
13/03/2017 Transfer of orphan designation EMA/70249/2017 (2017)1705 of 09/03/2017