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Register of orphan medicinal products


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Product information

Autologous T cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19

EU orphan designation number: EU/3/14/1266   
Active ingredient: Autologous T cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19
Indication: Treatment of B-lymphoblastic leukaemia/lymphoma
Sponsor: Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Kymriah on 23/08/2018 with the number EU/1/18/1297

   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
1/05/2014 Orphan designation EMA/OD/187/13 (2014)2972 of 29/04/2014
29/08/2014 Change of name and/or address of sponsor
18/05/2018 Transfer of orphan designation EMA/OD/187/13/T/01 (2018)3145 of 16/05/2018
19/07/2018 Other procedure