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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:
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
PREA(P):
P
Sponsor:
Bayer
NNPS:
TRUE'
Therapeutic Category:
Contraceptive
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