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Community register of orphan medicinal products


Product information


EU orphan designation number: EU/3/07/524   
Active ingredient: (R)-2-Methyl-6-nitro-2-{4-[4-(4-trifluoromethoxyphenoxy)piperidin-1-yl]phenoxymethyl}-2,3-dihydroimidazo[2,1-b]oxazole
Indication: Treatment of tuberculosis
Sponsor: Otsuka Novel Products GmbH
Erika-Mann-Straße 21, 80636 München, Deutschland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Deltyba on 28/04/2014 with the number EU/1/13/875

   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
05/02/2008 Orphan designation EMEA/OD/094/07 (2008)488 of 01/02/2008
29/09/2011 Transfer of orphan designation EMEA/OD/094/07/T/01 (2011)7051 of 27/09/2011