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New Pediatric Labeling Information Database - Detail
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Pediatrics
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]
PREA(P):
P
Sponsor:
Institut Biochimique SA
NNPS:
FALSE
Therapeutic Category:
Anti-inflammatory, topical
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