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Pharmaceuticals - Union Register

  

Register of orphan medicinal products


GRANTED  

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
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Mepsevii on 23/08/2018 with the number EU/1/18/1301

   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