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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:
08/03/2018
Trade Name:
Nuvessa
Generic Name or Proper Name (*):
metronidazole
Indications Studied:
Bacterial vaginosis
Label Changes Summary:
*Safety and effectiveness have been established in pediatric patients 12 years and older. *Use in this age group of patients 12 to less than 18 years is supported by evidence from a multicenter, open-label safety and tolerability study in 60 pediatric patients with bacterial vaginosis and, evidence from adequate and well-controlled studies in adult women. *Safety and effectiveness in pediatric patients below the age of 12 years have not been established. *Safety was similar to that observed in adults. *Information on adverse reactions and clinical trial. *Postmarketing study.
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Chemo Research SL
NNPS:
FALSE
Therapeutic Category:
Antibiotic, topical
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