EMEA-001313-PIP01-12-M13 - paediatric investigation plan

ceftazidime

avibactam

Key facts

• Invented name:
  • Zavicefta
  • Zavicefta
• Active substance:
  • ceftazidime
  • avibactam
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0551/2022
• PIP number:
  EMEA-001313-PIP01-12-M13
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  • Treatment of infections due to aerobic Gram-negative bacteria
  • Treatment of intra-abdominal infections
  • Treatment of pneumonia
  • Treatment of urinary tract infections
• 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:
  Sim
• Compliance procedure number:
  EMEA-C-001313-PIP01-12-M13
• Compliance opinion date:
  10/11/2023
• Compliance outcome:
  Positive

Decision

P/0551/2022 : EMA decision of 4 January 2023 on the acceptance of a modification of an agreed paediatric investigation plan for ceftazidime / avibactam (Zavicefta), (EMEA-001313-PIP01-12-M13)

Reference Number: EMA/950362/2022