EMEA-002283-PIP01-17-M04 - paediatric investigation plan

aztreonam (ATM)

avibactam (AVI)

Key facts

• Active substance:
  • aztreonam (ATM)
  • avibactam (AVI)
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0553/2022
• PIP number:
  EMEA-002283-PIP01-17-M04
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of infections caused by 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:
  04/01/2023
• Compliance check done:
  No

Decision

P/0553/2022: EMA decision of 4 January 2023 on n the acceptance of a modification of an agreed paediatric investigation plan for avibactam / aztreonam (EMEA-002283-PIP01-17-M04)

Reference Number: EMA/1707/2023