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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:
12/12/2018
Trade Name:
Exjade; Jadenu
Generic Name or Proper Name (*):
deferasirox
Indications Studied:
Transfusion-dependent anemia requiring chelation therapy due to iron overload
Label Changes Summary:
*A trial conducted in treatment naïve pediatric patients, ages 2 years to less than 18 years with transfusional iron overload did not include a sufficient number of patients to provide additional meaningful information about the safety or compliance of the deferasirox oral tablet for suspension dosage form (Exjade) compared to the deferasirox granules dosage form (Jadenu Sprinkle).
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Novartis
NNPS:
FALSE
Therapeutic Category:
Iron chelator
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