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New Pediatric Labeling Information Database - Detail
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Pediatrics
New Pediatric Labeling Information Database
Detail
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Pediatric Labeling Date:
12/10/2013
Trade Name:
Xeloda
Generic Name or Proper Name (*):
capecitabine
Indications Studied:
Newly diagnosed brainstem gliomas and high grade gliomas
Label Changes Summary:
The safety and effectiveness in pediatric patients have not been established No clinical benefit was demonstrated in 2 single arm trials in pediatric patientsThe adverse reaction (AR) profile was consistent with the known AR profile in adults, with the exception of laboratory abnormalities which occurred more commonly in pediatric patientsInformation on dosing, adverse reactions, and clinical trials
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Hoffman- LaRoche
NNPS:
FALSE'
Therapeutic Category:
Antineoplastic
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