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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

   Public summary of scientific opinion    

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