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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:  12/19/2014
 
Trade Name:  Merrem I.V.
 
Generic Name or Proper Name (*):  meropenem
 
Indications Studied:  Complicated intra-abdominal infections
 
Label Changes Summary:  *Indication extended to pediatric patients less than 3 months of age with intra-abdominal infections *Efficacy for cIAI upported by evidence from adequate and well-controlled studies in adults with additional data from a pediatric PK and safety study *A PK study was conducted in pediatric patients less than 3 months of age, including preterm infants. *Dosing for patients with normal renal function in this age group is based on gestational age and postnatal age. *Off-patent Written Request.
 
Product Labeling:  [INVALID]  Opens a new window
 
BPCA(B) and PREA(P):  B
 
Sponsor:  AstraZeneca
 
Therapeutic Category:  Antibiotic
 
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