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Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium; 2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylate

EU orphan designation number: EU/3/06/401   
Active ingredient: N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium; 2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylate
Indication: Treatment of familial amyloid polyneuropathy
Sponsor: Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Vyndaqel on 16/11/2011 with the number EU/1/11/717

   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
31/08/2006 Orphan designation EMEA/OD/032/06 (2006)3939 of 28/08/2006
08/07/2009 Corrigendum (2009)5408 of 01/07/2009
15/09/2009 Transfer of orphan designation EMEA/OD/032/06/T/01 (2009)7052 of 14/09/2009
24/08/2011 Change of name and/or address of sponsor EMEA/OD/032/06
01/06/2012 Transfer of orphan designation EMEA/OD/032/06/T/02 (2012)3646 of 25/05/2012