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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:
06/29/2016
Trade Name:
Kovanaze Nasal Spray
Generic Name or Proper Name (*):
tetracaine HCl and oxymetazoline HCl
Indications Studied:
Regional anesthesia when performing a restorative procedure on teeth 4-13 and A-J in adults and children who weigh 40 kg or more
Label Changes Summary:
*Approved in adults and children who weigh 40 kg or more *Kovanaze has not been studied in pediatric patients under 3 years and is not advised for use in pediatric patients weighing less than 40 kg because efficacy has not been demonstrated in these patients *Information on adverse reactions in adults and pediatric patients, clinical trial, PK * New drug
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
St. Renatus, LLC
NNPS:
FALSE
Therapeutic Category:
Anesthetic, topical
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