Navigation path

Pharmaceuticals - Union Register

  

Register of orphan medicinal products


GRANTED  

Product information

1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt

EU orphan designation number: EU/3/18/2057   
Active ingredient: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt
Indication: Treatment of acute myeloid leukaemia
Sponsor: Pharm Research Associates (UK) Limited
500 South Oak Way, Green Park, Reading, Berkshire RG2 6AD, United Kingdom

  

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/051/18 (2018)5729 of 24/08/2018