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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:  03/01/2019
 
Trade Name:  Flector Topical System
 
Generic Name or Proper Name (*):  diclofenac epolamine
 
Indications Studied:  Topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older
 
Label Changes Summary:  *Safety and effectiveness have been established in pediatric patients 6 years and older based on evidence from adequate and well-controlled studies in adults, as well as an open-label study in 104 pediatric patients 6 years and older. *The safety profile of Flector topical system in pediatric patients is similar to that in adults. *Safety and effectiveness have not been investigated in pediatric patients less than 6 years old. *Information on adverse reactions, PK parameters and clinical trial. *Postmarketing study.
 
Product Labeling:  [INVALID]  Opens a new window
 
PREA(P):  P
 
Sponsor:  Institut Biochimique SA
 
NNPS:  FALSE
 
Therapeutic Category:  Anti-inflammatory, topical
 
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