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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.
64 avenue Pierre Grenier, 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
22/05/2017 Change of name and/or address of sponsor