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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:  11/29/2007
 
Trade Name:  Triesence 40mg/mL
 
Generic Name or Proper Name (*):  triamcinolone acetonide injectable suspension
 
Indications Studied:  Visualization during vitrectomy
 
Label Changes Summary:  * Efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids, which is similar in pediatric and adult populations * Adverse effects of corticosteroids in pediatric patients are similar to those in adults * New indication
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Alcon Research, Ltd.
 
NNPS:  TRUE
 
Therapeutic Category:  Anti-inflammatory, topical
 
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