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Community register of orphan medicinal products


Product information

(S)-ethyl 2-amino-3-(4-(2-amino-6-((R)-1-(4-chloro-2-(3-methyl-1H-pyrazol-1-yl)phenyl)-2,2,2-trifluoroethoxy)pyrimidin-4-yl)phenyl)propanoate

EU orphan designation number: EU/3/09/661   
Active ingredient: (S)-ethyl 2-amino-3-(4-(2-amino-6-((R)-1-(4-chloro-2-(3-methyl-1H-pyrazol-1-yl)phenyl)-2,2,2-trifluoroethoxy)pyrimidin-4-yl)phenyl)propanoate
Indication: Treatment of carcinoid syndrome
Sponsor: Ipsen Pharma
65 quai Georges Gorse, 92100 Boulogne-Billancourt, France
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Xermelo on 18/09/2017 with the number EU/1/17/1224

   Public summary of scientific opinion     EPAR

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
12/10/2009 Orphan designation EMEA/OD/047/09 (2009)7859 of 08/10/2009
08/04/2015 Transfer of orphan designation EMA/OD/047/09/T/01 (2015)2364 of 01/04/2015
01/06/2016 Amendment of orphan designation EMEA/OD/047/09 (2016)3427 of 30/05/2016