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Community register of orphan medicinal products


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Product information

Adeno-associated viral vector of serotype 5 containing the human alanine-glyoxylate aminotransferase gene

EU orphan designation number: EU/3/12/974   
Active ingredient: Adeno-associated viral vector of serotype 5 containing the human alanine-glyoxylate aminotransferase gene
Indication: Treatment of primary hyperoxaluria type 1
Sponsor: uniQure Biopharma B.V.
Paasheuvelweg 25, 1105 BP, Amsterdam, Nederland

   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
27/03/2012 Orphan designation EMA/OD/123/11 (2012)2016 of 21/03/2012
17/07/2012 Change of name and/or address of sponsor EMEA/OD/123/11
22/05/2017 Change of name and/or address of sponsor