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Pharmaceuticals - Union Register


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, 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
5/12/2007 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