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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:  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  Opens a new window
 
PREA(P):  P
 
Sponsor:  Chemo Research SL
 
NNPS:  FALSE
 
Therapeutic Category:  Antibiotic, topical
 
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