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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:
02/03/2011
Trade Name:
Makena
Generic Name or Proper Name (*):
hydroxyprogesterone caproate
Indications Studied:
Reduce the risk of preterm birth
Label Changes Summary:
Safety and effectiveness in pediatric patients <16 years have not been establishedA small number of women < 18 years were studied; safety and efficacy are expected to be the same in women aged 16 years and above as for users 18 years and olderInformation on clinical trial
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Hologic, Inc.
NNPS:
TRUE'
Therapeutic Category:
Progestin
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