• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

  • Print
  • Share
  • E-mail
-
 
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
 
PREA(P):  P
 
Sponsor:  Bayer
 
NNPS:  TRUE
 
Therapeutic Category:  Contraceptive
 
-
-