Reason for request

Inclusion for an extension of the indication.


Clinical Benefit


The actual benefit is substantial for children who have not responded to conventional therapy.

Clinical Added Value


Considering not only the rareness of the condition and its more severe forms in children rather than adults, but also the similar clinical results obtained for REMICADE in both adults and children for the clinical criteria for ulcerative colitis.
the Transparency Committee has awarded REMICADE a significant IAB (levelII) in the treatment strategy of children and adolescents aged 6 to 17 years with active ulcerative colitis, who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.

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