EMEA-002133-PIP01-17-M03 - paediatric investigation plan

Cefiderocol

Key facts

• Invented name:
  Fetcroja
• Active Substance:
  Cefiderocol
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0441/2022
• PIP number:
  EMEA-002133-PIP01-17-M03
• 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:
  28/10/2022

Decision

P/0441/2022 : EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for cefiderocol (Fetcroja), (EMEA-002133-PIP01-17-M03)

AdoptedReference Number: EMA/788938/2022