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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:
05/30/2012
Trade Name:
Torisel
Generic Name or Proper Name (*):
temsirolimus
Indications Studied:
Advanced recurrent/refractory solid tumors
Label Changes Summary:
* Effectiveness in pediatric patients has not been established * Torisel was studied in 59 patients 1 - 17 years and 12 patients 18 to 21 years in a phase 1-2 safety and exploratory pharmacodynamic study * Adverse reactions were similar to those observedd in adults * Information on dosing, clinical trials and PK parameters
Product Labeling:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022088s014lbl.pdf
BPCA(B):
B
NNPS:
FALSE
Therapeutic Category:
Antineoplastic
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