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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:  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  Opens a new window
 
BPCA(B):  B
 
NNPS:  FALSE
 
Therapeutic Category:  Antineoplastic
 
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