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Community register of orphan medicinal products


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Product information

Recombinant adeno-associated viral vector containing human acid alfa-glucosidase-gene

EU orphan designation number: EU/3/12/1018   
Active ingredient: Recombinant adeno-associated viral vector containing human acid alfa-glucosidase-gene
Indication: Treatment of glycogen storage disease type II (Pompe's disease)
Sponsor: Audentes Therapeutics UK Limited
c/o Hackwood Secretaries Limited, One Silk Street, London EC2Y 8HQ, United Kingdom

   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
06/07/2012 Orphan designation EMA/OD/018/12 (2012)4772 of 04/07/2012
19/01/2016 Transfer of orphan designation EMA/OD/OD/018/12/T/01 (2016)254 of 15/01/2016