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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:  01/09/2013
 
Trade Name:  Skyla
 
Generic Name or Proper Name (*):  levonorgestrel-releasing intrauterine system
 
Indications Studied:  Prevention of pregnancy for up to 3 years
 
Label Changes Summary:  Safety and efficacy have been established in women of reproductive ageEfficacy is expected to be the same for postpubertal females under the age of 18 years as for users 18 years and olderUse of this product before menarche is not indicatedNew drug
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Bayer
 
NNPS:  TRUE'
 
Therapeutic Category:  Contraceptive
 
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