Reason for request

Inclusion

-


Clinical Benefit

Substantial

The actual benefit of XALUPRINE is substantial in the MarketingAuthorisation indication.


Clinical Added Value

minor

XALUPRINE provides a minor improvement in actual benefit (IAB IV) compared with mercaptopurine in tablet form in the treatment of acute lymphoblastic leukaemia in children (paediatric population).

no clinical added value

In adults and adolescents, XALUPRINE does not provide any improvement in actual benefit (IAB V, non-existent)compared with mercaptopurine in tablet form in the treatment of acute lymphoblastic leukaemia.