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Pharmaceuticals - Community Register


Community list of not active orphan medicinal products


Product information


EU orphan designation number: EU/3/01/025
Active ingredient: N-acetylgalactosamine-4-sulfatase
Indication: Treatment of Mucopolysaccharidosis, type VI (Maroteaux-Lamy Syndrome)
Sponsor: BioMarin Europe Ltd
164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Naglazyme on 24/01/2006 with the number EU/1/05/324

   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
22/02/2001 Orphan designation EMEA/OD/051/00 (2001)362 of 14/02/2001
05/12/2002 Transfer of orphan designation EMEA/OD/051/00/T/01 (2002)4591 of 28/11/2002
14/01/2005 Transfer of orphan designation EMEA/OD/051/00/T/02 (2005)4 of 11/01/2005
25/02/2009 Change of name and/or address of sponsor
26/01/2016 Removal of orphan designation from Community Register