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Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

Recombinant antibody derivative against human CD19 and CD3

EU orphan designation number: EU/3/03/176   
Active ingredient: Recombinant antibody derivative against human CD19 and CD3
Indication: Treatment of chronic lymphocytic leukaemia
Sponsor: Amgen Europe B.V.
Minervum 7061, 4817 ZK Breda, Nederland

   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
03/12/2003 Orphan designation EMEA/OD/054/03 (2003)4595 of 01/12/2003
31/01/2012 Change of name and/or address of sponsor EMEA/OD/054/03
19/06/2012 Change of name and/or address of sponsor EMEA/OD/054/03
14/02/2014 Transfer of orphan designation EMEA/OD/054/03/T/01 (2014)1030 of 12/02/2014