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Community register of orphan medicinal products


Product information

(3-[5-(2-fluoro-phenyl)-[1,2,4]oxadiazole-3-yl]-benzoic acid

EU orphan designation number: EU/3/05/278   
Active ingredient: (3-[5-(2-fluoro-phenyl)-[1,2,4]oxadiazole-3-yl]-benzoic acid
Indication: Treatment of Duchenne muscular dystrophy
Sponsor: PTC Therapeutics International Limited
5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Translarna on 31/07/2014 with the number EU/1/13/902

   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
31/05/2005 Orphan designation EMEA/OD/106/04 (2005)1655 of 27/05/2005
22/05/2007 Transfer of orphan designation EMEA/OD/106/04/T/01 (2007)2144 of 14/05/2007
26/04/2012 Transfer of orphan designation EMEA/OD/106/04/T/02 (2012)2898 of 23/04/2012
02/08/2013 Change of name and/or address of sponsor
12/06/2014 Other procedure
05/08/2014 Change of name and/or address of sponsor
08/10/2014 Transfer of orphan designation EMA/OD/106/04/T/03 (2014)7396 of 06/10/2014
07/07/2017 Change of name and/or address of sponsor