Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
  • Print
  • Share
  • E-mail
-
 
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:  Labeling  Opens a new window
 
BPCA(B):  B
 
NNPS:  FALSE'
 
Therapeutic Category:  Antineoplastic
 
-
-