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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:  08/10/2018
 
Trade Name:  Annovera
 
Generic Name or Proper Name (*):  segesterone acetate and ethinyl estradiol vaginal system
 
Indications Studied:  Prevention of pregnancy
 
Label Changes Summary:  *Safety and efficacy of have been established in women of reproductive age. *Efficacy is expected to be the same for postpubertal adolescents under the age of 18 as for users 18 years and older. *Use before menarche is not indicated. *New drug.
 
Product Labeling:  Labeling  Opens a new window
 
Sponsor:  The Population Council, Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Contraceptive
 
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