Ampicillin + Sulbactam

For which indications is the combination Ampicillin + Sulbactam FDA or EMA approved?

• FDA-approved indications (1)

  
  
  • Skin and skin-structure infections
  
  
  • Intra-abdominal infections
  
  
  • Gynecological infections
  
  
  
  



• Pediatric FDA indication (1)
  For children who are one year of age and older, the safety and effectiveness of the treatment have been specifically established for skin and skin-structure infections, similar to the adult indication. According to the FDA label, efficacy has not been established in pediatric patients for intra-abdominal infections




• European Union: no centralized EMA indication (2)

  
  
  • Germany (no centralized EMA indication)
    
    
    • Severe acute ear, nose and throat infections
    
    
    • Acute exacerbations of chronic bronchitis
    
    
    • Community-acquired pneumonia
    
    
    • Kidney and urinary-…