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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:
05/13/2010
Trade Name:
Taxotere
Generic Name or Proper Name (*):
docetaxel
Indications Studied:
Solid Tumors
Label Changes Summary:
Efficacy in pediatric patients as monotherapy or in combination has not been established. Taxotere has been studied in a total of 289 pediatric patients: 239 in 2 trials with monotherapy and 50 in combination treatment with cisplatin and 5-fluoruracil The overall safety profile in pediatric patients receiving monotherapy or combination treatment was consistent with the safety profile in adults Information on dosing, clinical trials and PK parameters
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Sanofi-Aventis
Pediatric Exclusivity Granted Date:
03/17/2010
NNPS:
FALSE'
Therapeutic Category:
Antineoplastic
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