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U.S. Department of Health and Human Services

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  Opens a new window
 
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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