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Pharmaceuticals - Community Register


Community list of not active orphan medicinal products


Product information

Imatinib mesilate

EU orphan designation number: EU/3/05/340
Active ingredient: Imatinib mesilate
Indication: Treatment of myelodysplastic / myeloproliferative diseases
Sponsor: Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Glivec on 27/08/2001 with the number EU/1/01/198

   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
03/01/2006 Orphan designation EMEA/OD/067/05 (2005)5974 of 23/12/2005
16/04/2012 Removal of orphan designation from Community Register