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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:
05/25/2005
Trade Name:
Merrem I.V.
Generic Name or Proper Name (*):
meropenem
Indications Studied:
Treatment of complicated skin and skin structure infections in children 3 months of age and older
Label Changes Summary:
*Supported by extrapolating safety and effectiveness from an adequate and well-controlled adult study and additional data from pediatric PK studies. *Studies waived for children < 3 months of age. *New indication.
Product Labeling:
[INVALID]
PREA(P):
P
Sponsor:
AstraZeneca
NNPS:
FALSE'
Therapeutic Category:
Antibiotic
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