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Community register of orphan medicinal products


Product information


EU orphan designation number: EU/3/07/513   
Active ingredient: (S)-2-nitro-6-(4-(trifluoromethoxy)benzyloxy)-6,7-dihydro-5H-imidazo[2,1-b][1,3]oxazine
Indication: Treatment of tuberculosis
Sponsor: FGK Representative Service GmbH
Heimeranstraße 35, D-80339 München, Deutschland

   Public summary of scientific opinion    

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
05/12/2007 Orphan designation EMEA/OD/074/07 (2007)6024 of 29/11/2007
28/05/2015 Change of name and/or address of sponsor
24/06/2015 Transfer of orphan designation EMA/OD/074/07/T/01 (2015)4331 of 19/06/2015