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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:  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:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  AstraZeneca
 
NNPS:  FALSE
 
Therapeutic Category:  Antibiotic
 
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