EMEA-002240-PIP02-17-M02 - paediatric investigation plan

Enmetazobactam

cefepime

Key facts

• Active substance:
  • Enmetazobactam
  • cefepime
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0340/2022
• PIP number:
  EMEA-002240-PIP02-17-M02
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of infections caused by gram-negative organisms
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  24/01/2023
• Compliance check done:
  No

Decision

P/0047/2023: EMA decision of 24 January 2023 on the acceptance of a modification of an agreed paediatric investigation plan for enmetazobactam (AAI101) / cefepime (EMEA-002240-PIP02-17-M02)

Reference Number: EMA/35874/2023