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Community register of orphan medicinal products


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Product information

Adenovirus associated viral vector serotype 4 containing the human RPE65 gene

EU orphan designation number: EU/3/07/484   
Active ingredient: Adenovirus associated viral vector serotype 4 containing the human RPE65 gene
Indication: Treatment of Leber's congenital amaurosis
Sponsor: HORAMA SA
Pépinière Paris Santé Cochin, 27 rue du Faubourg Saint-Jacques, 75014 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
24/10/2007 Orphan designation EMEA/OD/072/07 (2007)5241 of 22/10/2007
12/05/2015 Transfer of orphan designation EMA/OD/072/07/T/01 (2015)3241 of 07/05/2015
29/11/2016 Change of name and/or address of sponsor
07/08/2017 Change of name and/or address of sponsor