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Community register of orphan medicinal products


Product information

(3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt

EU orphan designation number: EU/3/10/760   
Active ingredient: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt
Indication: Treatment of ovarian cancer
Sponsor: TESARO U.K. Limited
55 Baker Street, London W1U 7EU, United Kingdom
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Zejula on 16/11/2017 with the number EU/1/17/1235

   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
06/08/2010 Orphan designation EMA/OD/015/10 (2010)5527 of 04/08/2010
19/12/2012 Transfer of orphan designation EMA/OD/015/10/T/01 (2012)9810 of 17/12/2012
09/10/2017 Change of name and/or address of sponsor