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Community register of orphan medicinal products


Product information


EU orphan designation number: EU/3/04/192   
Active ingredient: 3-(4'aminoisoindoline-1'-one)-1-piperidine-2,6-dione
Indication: Treatment of myelodysplastic syndromes
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
10/03/2004 Orphan designation EMEA/OD/083/03 (2004)801 of 08/03/2004
29/07/2005 Transfer of orphan designation EMEA/OD/083/03/T/01 (2005)2952 of 27/07/2005
06/06/2008 Change of name and/or address of sponsor
16/09/2008 Change of name and/or address of sponsor
30/05/2011 Change of name and/or address of sponsor EMEA/OD/083/03