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Register of orphan medicinal products


GRANTED  

Product information

4-amino-1-[(1S,4R,5S)-2-fluoro-4,5-dihydroxy-3-(hydroxymethyl)cyclopent-2-en-1-yl]pyrimidin-2-one

EU orphan designation number: EU/3/17/1937   
Active ingredient: 4-amino-1-[(1S,4R,5S)-2-fluoro-4,5-dihydroxy-3-(hydroxymethyl)cyclopent-2-en-1-yl]pyrimidin-2-one
Indication: Treatment of pancreatic cancer
Sponsor: IQVIA RDS Ireland Limited
Estuary House, East Point Business Park, Fairview, Dublin 3, DO3 Y6A2, Ireland

   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
10/11/2017 Orphan designation EMA/OD/118/17 (2017)7559 of 8/11/2017
2/05/2018 Change of name and/or address of sponsor