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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:
03/18/2016
Trade Name:
OraVerse Injection
Generic Name or Proper Name (*):
phentolamine mesylate
Indications Studied:
Reversal of soft-tissue anesthesia
Label Changes Summary:
* Expanded indication down to pediatric patients 3 years and older; previously approved in 6 years and older. * Safety and efficacy have not been established in patients younger than 3 years. • Information on dosing and PK. * Postmarketing study
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Septodent Holding SAS
NNPS:
FALSE
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