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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:
09/27/2006
Trade Name:
Gleevec
Generic Name or Proper Name (*):
imatinib mesylate
Indications Studied:
Treatment of newly diagnosed pediatric patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
Label Changes Summary:
Extended age range for the treatment of newly diagnosed CML down to pediatric patients There are no data in children < 2 years of age Follow-up in children with newly diagnosed Ph+ chronic phase CML is limited Information on hematologic toxicities, AE profile, clinical studies and dosing guidelines new for newly diagnosed pediatric patients
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B, P
Sponsor:
Novartis
Pediatric Exclusivity Granted Date:
06/09/2006
NNPS:
FALSE'
Therapeutic Category:
Antineoplastic
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