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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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