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Pharmaceuticals - Community Register

  

Community list of not active orphan medicinal products


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Product information

(Z)-N-[2-(Diethylamino)ethyl]-5-[(5-fluoro-2-oxo-1,2-dihydro-3Hindol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (S)-2-hydroxysuccinate

EU orphan designation number: EU/3/05/267
Active ingredient: (Z)-N-[2-(Diethylamino)ethyl]-5-[(5-fluoro-2-oxo-1,2-dihydro-3Hindol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (S)-2-hydroxysuccinate
Indication: Treatment of malignant gastrointestinal stromal tumours
Sponsor: Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Sutent on 19/07/2006 with the number EU/1/06/347

   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
14/03/2005 Centralised Orphan - Designation EMEA/OD/084/04 (2005)810 of 10/03/2005
23/07/2008 Centralised Orphan - Removal of orphan designation from Community Register