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Community register of orphan medicinal products


GRANTED  

Product information

N-[4-[[(2-amino-3,4-dihydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-D-gamma-glutamyl-(2S)-2-amino-beta-alanyl-L-alpha-aspartyl-L-cysteine to be used with folic acid

EU orphan designation number: EU/3/12/1043   
Active ingredient: N-[4-[[(2-amino-3,4-dihydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-D-gamma-glutamyl-(2S)-2-amino-beta-alanyl-L-alpha-aspartyl-L-cysteine to be used with folic acid
Indication: Diagnosis of positive folate receptor status in ovarian cancer
Sponsor: Voisin Consulting S.A.R.L.
3 rue des Longs Prés, F-92100 Boulogne-Billancourt, France

   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
12/09/2012 Orphan designation EMA/OD/055/12 (2012)6369 of 10/09/2012
21/12/2016 Transfer of orphan designation EMA/OD/055/12/T/01 (2016)8910 of 19/12/2016