Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information

Sialic acid

EU orphan designation number: EU/3/12/972   
Active ingredient: Sialic acid
Indication: Treatment of GNE myopathy
Sponsor: Ultragenyx Germany GmbH
Stadtquartier Friedrichstraße 191, 10117 Berlin, Deutschland

   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
07/03/2012 Orphan designation EMA/OD/126/11 (2012)1537 of 05/03/2012
02/01/2014 Transfer of orphan designation EMA/OD/126/11/T/01 (2013)9814 of 20/12/2013
28/04/2015 Transfer of orphan designation EMA/OD/126/11/T/02 (2015)2954 of 24/04/2015
20/10/2015 Amendment of orphan designation EMA/OD/126/11 (2015)7313 of 16/10/2015
31/01/2017 Transfer of orphan designation EMA/OD/0126/11/T/03 (2017)531 of 26/01/2017