Reason for request

Extension of indication

-   


Clinical Benefit

Substantial

The actual benefit of CERUBIDINE 20 mg is substantial, as part of a combination chemotherapy regimen, in the treatment of acute lymphoblastic leukaemia and acute myeloblastic leukaemia in children.


Clinical Added Value

no clinical added value

CERUBIDINE 20 mg does not provide any improvement in actual benefit (level V, non-existent) in the treatment of acute lymphoblastic and myeloblastic leukaemia in children.