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Community register of orphan medicinal products


Product information

Recombinant human beta-glucuronidase

EU orphan designation number: EU/3/12/973   
Active ingredient: Recombinant human beta-glucuronidase
Indication: Treatment of mucopolysaccharidosis type VII (Sly syndrome)
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
23/03/2012 Orphan designation EMA/OD/127/11 (2012)2017 of 21/03/2012
2/01/2014 Transfer of orphan designation EMA/OD/127/11/T/01 (2013)9815 of 20/12/2013
11/05/2015 Transfer of orphan designation EMA/OD/127/11/T/02 (2015)3244 of 7/05/2015
28/09/2016 Transfer of orphan designation EMA/OD/127/11/T/03 (2016) 6313 of 26/09/2016
3/07/2018 Other procedure