EMEA-002892-PIP01-20 - paediatric investigation plan

cefepime

zidebactam

Key facts

• Active substance:
  • cefepime
  • zidebactam
• Therapeutic area:
  • Infectious diseases
  • Neonatology-Paediatric Intensive Care
  • Uro-nephrology
• Decision number:
  P/0330/2021
• PIP number:
  EMEA-002892-PIP01-20
• Pharmaceutical form(s):
  Powder for solution for infusion
• Condition(s) / indication(s):
  Treatment of complicated urinary tract infections
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  11/08/2021
• Compliance check done:
  No

Decision

P/0330/2021 : EMA decision of 11 August 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for cefepime / zidebactam (EMEA-002892-PIP01-20)

Adopted Reference Number: EMA/418666/2021