EMEA-000205-PIP02-11-M07 - paediatric investigation plan

ceftobiprole medocaril (sodium)

Key facts

• Invented name:
  Zevtera and associated names
• Active substance:
  ceftobiprole medocaril (sodium)
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0299/2024
• PIP number:
  EMEA-000205-PIP02-11-M07
• 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:
  16/08/2024
• Compliance check done:
  No

Decision

P/0299/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for ceftobiprole medocaril (sodium) (Zevtera and associated names), (EMEA-000205-PIP02-11-M07)

Adopted Reference Number: EMA/320724/2024