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Register of orphan medicinal products


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Product information

Adeno-associated viral vector serotype 9 containing the human mini-dystrophin gene

EU orphan designation number: EU/3/16/1716   
Active ingredient: Adeno-associated viral vector serotype 9 containing the human mini-dystrophin gene
Indication: Treatment of Duchenne muscular dystrophy
Sponsor: Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

   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
31/08/2016 Orphan designation EMA/OD/096/16 (2016)5618 of 29/08/2016
23/05/2017 Transfer of orphan designation EMA/OD/096/16/T/01 (2017)3613 of 22/05/2017
21/11/2018 Transfer of orphan designation EMA/OD/096/16/T/02 (2018)7837 of 19/11/2018