EMEA-001142-PIP02-16 - paediatric investigation plan

Ceftolozane

tazobactam

Key facts

• Invented name:
  • Zerbaxa
  • Zerbaxa
• Active Substance:
  • Ceftolozane
  • tazobactam
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0552/2022
• PIP number:
  EMEA-001142-PIP02-16
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of pneumonia
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Merck Sharp & Dohme (Europe), Inc.

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  04/01/2023

Decision

P/0552/2022 : EMA decision of 4 January 2023 on the acceptance of a modification of an agreed paediatric investigation plan for ceftolozane / tazobactam (Zerbaxa), (EMEA-001142-PIP02-16-M01)