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