EMEA-002133-PIP01-17-M04 - paediatric investigation plan

cefiderocol

Key facts

• Invented name:
  Fetcroja
• Active substance:
  cefiderocol
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0337/2024
• PIP number:
  EMEA-002133-PIP01-17-M04
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of infections due to aerobic Gram-negative bacteria
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/09/2024
• Compliance check done:
  No

Decision

P/0337/2024 : EMA decision of 13 September 2024 on the acceptance of a modification of an agreed paediatric investigation plan for cefiderocol (Fetcroja), (EMEA-002133-PIP01-17-M04)

Adopted Reference Number: EMA/414241/2024