8 results
Keyword Spirofur Remove keyword
-
List item
Opinion/decision on a Paediatric investigation plan (PIP): [N-((2S,3R,3aS,3´R,4a´R,6S,6a´R,6b´S,7aR,12a´S,12b´S,Z)-3,6,11´,12b´-tetramethyl-2´,3a,3´,4,4´,4a´,5,5´,6,6´,6a´,6b´,7,7a,7´,8´,10´,12´,12a´,12b´-icosahydro-1´H,3Hspiro[furo[3,2-b]pyridine-2,9´-naphtho[2,1-a]azulene]-3´-yl)methanesulfonamide hydrochloride]
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001277-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 21/08/2012, Last updated: 18/09/2012, Compliance check: XN- ((2S,3R,3aS,3´R,4a´R,6S,6a´R,6b´S,7aR,12a´S,12b´S,Z)-3,6,11´,12b´-tetramethyl- 2´,3a,3´,4,4´,4a´,5,5´,6,6´,6a´,6b´,7,7a,7´,8´,10´,12´,12a´,12b´-icosahydro-1´H,3H- spiro[furo[3,2-b]pyridine-2,9´-naphtho[2,1-a]azulene]-3´-yl)methanesulfonamide … N- ((2S,3R,3aS,3´R,4a´R,6S,6a´R,6b´S,7aR,12a´S,12b´S,Z)-3,6,11´,12b´-tetramethyl- 2´,3a,3´,4,4´,4a´,5,5´,6,6´,6a´,6b´,7,7a,7´,8´,10´,12´,12a´,12b´-icosahydro-1´H,3H- spiro[furo[3,2-b]pyridine-2,9´-naphtho[2,1-a]azulene]-3´-yl)methanesulfonamide … -
List item
Committee for Orphan Medicinal Products (COMP): 8-9 February 2011
European Medicines Agency, London, UK, from 08/02/2011 to 09/02/2011, Last updated: 11/06/2010N-((2S,3R,3aS,3'R,4a'R,6S,6a'R,6b'S,7aR,12a'S,12b'S,Z)-3,6,11',12b'-tetramethyl- 2',3a,3',4,4',4a',5,5',6,6',6a',6b',7,7a,7',8',10',12',12a',12b'-icosahydro-1'H,3H- spiro[furo[3,2-b]pyridine-2,9'-naphtho[2,1-a]azulene]-3'-yl)methanesulfonamide … -
List item
Paediatric Commitee (PDCO): 4-6 July 2012
Paul-Ehrlich Institut, Germany, from 04/07/2012 to 06/07/2012, Last updated: 25/10/2011 -
List item
COMP: meeting archive 2007-2011
Last updated: 16/09/2013 -
List item
News: Annual report 2011 shows continuously high level of activities
Last updated: 06/06/2012 -
List item
Annual reports and work programmes
Last updated: 28/06/2023 -
List item
Public data from Article 57 database
Last updated: 30/06/2023 -
List item
PDCO: meeting archive 2012-2014
Last updated: 03/06/2016