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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:
11/05/2002
Trade Name:
Navelbine
Generic Name or Proper Name (*):
vinorelbine
Indications Studied:
Malignant tumors
Label Changes Summary:
New data from a single-arm study in 46 patients with recurrent solid malignant tumors, including rhabdomyosarcoma /undifferentiated sarcoma, neuroblastoma, and CNS tumors, at doses similar to those used in adults showed no meaningful clinical activity
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
GlaxoSmithKline
Pediatric Exclusivity Granted Date:
08/15/2002
NNPS:
FALSE'
Therapeutic Category:
Antineoplastic
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