EMEA-000205-PIP02-11-M05 - paediatric investigation plan

Ceftobiprole medocaril (sodium)

Key facts

• Invented name:
  • Zevtera and associated names
  • Zeftera (previously Zevtera)
• Active Substance:
  Ceftobiprole medocaril (sodium)
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0529/2021
• PIP number:
  EMEA-000205-PIP02-11-M05
• 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:

  Basilea Pharmaceutica International Ltd

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  03/12/2021

Decision

P/0529/2021 : EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for ceftobiprole medocaril (sodium), (Zevtera and associated names), (EMEA-000205-PIP02-11-M05)

Reference Number: EMA/626229/2021