EMA/PE/0000247019 - paediatric investigation plan

Enmetazobactam

cefepime

Key facts

• Invented name:
  Exblifep
• Active substance:
  • Enmetazobactam
  • cefepime
• Therapeutic area:
  • Infections and infestations
  • Infectious diseases
• Decision number:
  EMA/PE/0000247019
• PIP number:
  EMA/PE/0000247019
• 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:
  10/07/2025
• Compliance check done:
  Nu

Decision

EMA/PE/0000247019 : EMA decision of 10 July 2025 on the acceptance of a modification of an agreed paediatric investigation plan for enmetazobactam / cefepime (Exblifep)

Adopted Reference Number: EMADOC-1700519818-2258889