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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:  09/24/2010
 
Trade Name:  Beyaz
 
Generic Name or Proper Name (*):  drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium
 
Indications Studied:  Prevention of pregnancy; premenstrual dysphoric disorder; moderate acne vulgaris e14 years who have achieved menarche; to raise folate levels in a pregnancy conceived while on or shortly after discontinuing the product
 
Label Changes Summary:  * Safety and efficacy have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents <18 years and for users e18 years * Use before menarche is not indicated * New combination
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Bayer
 
NNPS:  TRUE
 
Therapeutic Category:  Contraceptive
 
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