Navigation path

Pharmaceuticals - Union Register

  

Register of orphan medicinal products


GRANTED  

Product information

Sodium (1R,3R,4R,5S)-3-({2-N-acetylamino-2-deoxy-3-O-[(1S)-1-carboxylato-2-cyclohexylethyl]-beta-D-galactopyranosyl}oxy)-4-({6-deoxy-alpha-L-galactopyranosyl}oxy)-5-ethyl-cyclohexan-1-yl-(38-oxo-2,5,8,11,14,17,20,23,26,29,32,35-dodecaoxa-39-azahentetracontan-41-yl)carboxamide

EU orphan designation number: EU/3/17/1876   
Active ingredient: Sodium (1R,3R,4R,5S)-3-({2-N-acetylamino-2-deoxy-3-O-[(1S)-1-carboxylato-2-cyclohexylethyl]-beta-D-galactopyranosyl}oxy)-4-({6-deoxy-alpha-L-galactopyranosyl}oxy)-5-ethyl-cyclohexan-1-yl-(38-oxo-2,5,8,11,14,17,20,23,26,29,32,35-dodecaoxa-39-azahentetracontan-41-yl)carboxamide
Indication: Treatment of acute myeloid leukaemia
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
23/05/2017 Orphan designation EMA/OD/010/17 (2017)3609 of 22/05/2017
28/03/2018 Transfer of orphan designation EMA/OD/010/17/T/01 (2018)2011 of 26/03/2018