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Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

Recombinant human N-acetylgalactosamine-6-sulfatase

EU orphan designation number: EU/3/09/657   
Active ingredient: Recombinant human N-acetylgalactosamine-6-sulfatase
Indication: Treatment of mucopolysaccharidosis, type IVA (Morquio A Syndrome)
Sponsor: BioMarin Europe Ltd.
10 Bloomsbury Way, London WC1A 2SL, United Kingdom
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Vimizim on 28/04/2014 with the number EU/1/14/914

   Public summary of scientific opinion     EPAR

European Commission proceduresGoto top of the page
Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
30/07/2009 Orphan designation EMEA/OD/017/09 (2009)6074 of 24/07/2009
19/02/2016 Change of name and/or address of sponsor