Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
  • Print
  • Share
  • E-mail
-
 
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]  Opens a new window
 
PREA(P):  P
 
Sponsor:  AstraZeneca
 
NNPS:  FALSE'
 
Therapeutic Category:  Antibiotic
 
-
-