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Pharmaceuticals - Community Register


Community list of not active orphan medicinal products


Product information

(R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate

EU orphan designation number: EU/3/09/620
Active ingredient: (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate
Indication: Treatment of myelofibrosis secondary to polycythemia vera or essential thrombocythemia
Sponsor: Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Jakavi on 23/08/2012 with the number EU/1/12/773

   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
08/04/2009 Orphan designation EMEA/OD/103/08 (2009)2751 of 03/04/2009
01/12/2009 Change of name and/or address of sponsor
30/09/2010 Transfer of orphan designation EMEA/OD/103/08/T/01 (2010)6811 of 28/09/2010
29/08/2014 Change of name and/or address of sponsor
20/02/2015 Removal of orphan designation from Community Register