EMEA-001142-PIP02-16-M02 - paediatric investigation plan

ceftolozane

tazobactam

Key facts

• Invented name:
  Zerbaxa
• Active substance:
  • ceftolozane
  • tazobactam
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0381/2024
• PIP number:
  EMEA-001142-PIP02-16-M02
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of pneumonia
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  24/10/2024
• Compliance check done:
  No

Decision

P/0381/2024: EMA decision of 24 October 2024 on the acceptance of a modification of an agreed paediatric investigation plan for ceftolozane / tazobactam (Zerbaxa) (EMEA-001142-PIP02-16-M02)

Adopted Reference Number: EMA/484870/2024