EMEA-001142-PIP01-11-M04 - paediatric investigation plan

ceftolozane

tazobactam

Key facts

• Invented name:
  Zerbaxa
• Active substance:
  • ceftolozane
  • tazobactam
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0436/2020
• PIP number:
  EMEA-001142-PIP01-11-M04
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  • Treatment of intra-abdominal infections
  • 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:
  13/11/2020
• Compliance check done:
  Ja
• Compliance procedure number:
  EMEA-C-001142-PIP01-11-M04
• Compliance opinion date:
  25/06/2021
• Compliance outcome:
  Positive

Decision

P/0436/2020 : EMA decision of 13 November 2020 on the acceptance of a modification of an agreed paediatric investigation plan for ceftolozane / tazobactam (Zerbaxa) (EMEA-001142-PIP01-11-M04)

Adopted Reference Number: EMA/593110/2020