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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
Sponsor:  AstraZeneca
Therapeutic Category:  Antibiotic