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Register of orphan medicinal products


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Adeno-associated viral vector serotype 8 encoding human ornithine transcarbamylase

EU orphan designation number: EU/3/16/1623   
Active ingredient: Adeno-associated viral vector serotype 8 encoding human ornithine transcarbamylase
Indication: Treatment of ornithine transcarbamylase deficiency
Sponsor: Pharma Gateway AB
Johanneslundsvägen 2, Hammarby, 194 61 Upplands Väsby, Stockholms Lan, Sverige

   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
29/03/2016 Orphan designation EMA/OD/227/15 (2016)1859 of 21/03/2016
13/06/2017 Change of name and/or address of sponsor