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Register of orphan medicinal products


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 International Limited
Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland
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
12/03/2014 Other procedure
19/02/2016 Change of name and/or address of sponsor
1/10/2018 Transfer of orphan designation EMEA/OD/017/09/T/01 (2018)6398 of 27/09/2018