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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:  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  Opens a new window
 
BPCA(B):  B
 
Sponsor:  GlaxoSmithKline
 
Pediatric Exclusivity Granted Date:  08/15/2002
 
NNPS:  FALSE
 
Therapeutic Category:  Antineoplastic
 
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