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Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

1-deoxygalactonojirimycin hydrochloride

EU orphan designation number: EU/3/06/368   
Active ingredient: 1-deoxygalactonojirimycin hydrochloride
Indication: Treatment of Fabry disease
Sponsor: Amicus Therapeutics UK Ltd
Phoenix House, Oxford Road, Tatling End, Gerrards Cross, Buckinghamshire SL9 7AP, United Kingdom
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Galafold on 26/05/2016 with the number EU/1/15/1082

   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
24/05/2006 Orphan designation EMEA/OD/105/05 (2006)2144 of 22/05/2006
04/07/2008 Transfer of orphan designation EMEA/OD/105/05/T/01 (2008)3294 of 25/06/2008
18/02/2010 Transfer of orphan designation EMEA/OD/105/05/T/02 (2010)969 of 12/02/2010
24/06/2011 Transfer of orphan designation EMEA/OD/105/05/T/03 (2011)4556 of 21/06/2011
04/02/2014 Change of name and/or address of sponsor
14/03/2014 Transfer of orphan designation EMEA/OD/105/05/T/04 (2014)1740 of 12/03/2014
19/02/2016 Change of name and/or address of sponsor