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Community register of orphan medicinal products


GRANTED  

Product information

Folic acid to be used with 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

EU orphan designation number: EU/3/12/1044   
Active ingredient: Folic acid to be used with 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
Indication: Diagnosis of positive folate receptor status in ovarian cancer
Sponsor: Endocyte Europe B.V.
Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Neocepri on with the number EU/1/14/926

   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 Centralised Orphan - Designation EMA/OD/056/12 (2012)6370 of 10/09/2012