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Register of orphan medicinal products


Product information

(1R,2S) 6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-(1-naphthyl)-beta-phenyl-3-quinolineethanol

EU orphan designation number: EU/3/05/314   
Active ingredient: (1R,2S) 6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-(1-naphthyl)-beta-phenyl-3-quinolineethanol
Indication: Treatment of tuberculosis
Sponsor: Janssen-Cilag International NV
Turnhoutseweg 30, 2340 Beerse, België
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Sirturo on 5/03/2014 with the number EU/1/13/901

   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
31/08/2005 Orphan designation EMEA/OD/024/05 (2005)3337 of 26/08/2005
9/12/2008 Transfer of orphan designation EMEA/OD/024/05/T/01 (2008)8161 of 4/12/2008
17/07/2012 Change of name and/or address of sponsor EMEA/OD/024/05
3/08/2012 Change of name and/or address of sponsor EMEA/OD/024/05
10/09/2012 Transfer of orphan designation EMEA/OD/024/05/T/02 (2012)6285 of 6/09/2012