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Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

3-(4´aminoisoindoline-l´-one)-1-piperidine-2,6-dione

EU orphan designation number: EU/3/03/177   
Active ingredient: 3-(4´aminoisoindoline-l´-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 Centralised Orphan - Designation EMEA/OD/063/03 (2003)5021 of 12/12/2003
28/07/2005 Centralised Orphan - Transfer of orphan designation EMEA/OD/063/03/T/01 (2005)2942 of 26/07/2005
06/06/2008 Other procedure
29/10/2008 Other procedure
30/05/2011 Other procedure EMEA/OD/063/03