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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 age*Efficacy is expected to be the same for postpubertal females under the age of 18 years as for users 18 years and older*Use of this product before menarche is not indicated*New drug
Product Labeling:    Opens a new window
Sponsor:  Bayer
Therapeutic Category:  Contraceptive