EMA/PE/0000227526 - paediatric investigation plan

ceftobiprole medocaril (sodium)

Key facts

• Invented name:
  • Zevtera and associated names
  • Zeftera (previously Zevtera)
• Active substance:
  ceftobiprole medocaril (sodium)
• Therapeutic area:
  Infections and infestations
• Decision number:
  EMA/PE/0000227526
• PIP number:
  EMA/PE/0000227526
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of pneumonia
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  28/01/2025
• Compliance check done:
  Nee

Decision

EMA/PE/0000227526 : EMA decision of 28 January 2025 on the acceptance of a modification of an agreed paediatric investigation plan for ceftobiprole medocaril sodium (Zevtera and associated names)

Adopted Reference Number: EMADOC-1700519818-1859875