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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:
08/13/2010
Trade Name:
ella
Generic Name or Proper Name (*):
ulipristal acetate
Indications Studied:
Prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure
Label Changes Summary:
Safety and efficacy have been established in women of reproductive age. Safety and efficacy are expected to be the same for post pubertal adolescents <18 years and for users 18 years and older. Use of ella before menarche is not indicated New drug
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Laboratoire HRA Pharma
NNPS:
TRUE'
Therapeutic Category:
Contraceptive
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