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Pharmaceuticals - Union Register

  

Register of orphan medicinal products


GRANTED  

Product information

(3R,3aS,9R,9aS,9bS)-3-((dimethylamino)methyl)-9-hydroxy-6,9-dimethyl-3,3a,4,5,7,8,9,9a-octahydroazuleno[4,5-b]furan-2(9bH)-one fumarate

EU orphan designation number: EU/3/18/2055   
Active ingredient: (3R,3aS,9R,9aS,9bS)-3-((dimethylamino)methyl)-9-hydroxy-6,9-dimethyl-3,3a,4,5,7,8,9,9a-octahydroazuleno[4,5-b]furan-2(9bH)-one fumarate
Indication: Treatment of glioma
Sponsor: IQVIA RDS Ireland Limited
Estuary House, East Point Business Park, Fairview, Dublin 3, DO3 Y6A2, Ireland

  

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
28/08/2018 Orphan designation EMA/OD/060/18 (2018)5727 of 24/08/2018