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Pharmaceuticals - Community Register


Community list of not active orphan medicinal products


Product information


EU orphan designation number: EU/3/03/177
Active ingredient: 3-(4'aminoisoindoline-1'-one)-1-piperidine-2,6-dione
Indication: Treatment of multiple myeloma
Sponsor: Celgene Europe Limited
1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Revlimid on 14/06/2007 with the number EU/1/07/391

   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
16/12/2003 Orphan designation EMEA/OD/063/03 (2003)5021 of 12/12/2003
28/07/2005 Transfer of orphan designation EMEA/OD/063/03/T/01 (2005)2942 of 26/07/2005
06/06/2008 Change of name and/or address of sponsor
29/10/2008 Change of name and/or address of sponsor
30/05/2011 Change of name and/or address of sponsor EMEA/OD/063/03
19/06/2017 Removal of orphan designation from Community Register