EMEA-001645-PIP01-14-M04 - paediatric investigation plan

Bezlotoxumab

Key facts

• Invented name:
  • Zinplava
  • Zinplava
• Active substance:
  Bezlotoxumab
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0135/2022
• PIP number:
  EMEA-001645-PIP01-14-M04
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Prevention of recurrence of Clostridioides difficile infection
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/04/2022
• Compliance check done:
  Taip
• Compliance procedure number:
  EMEA-C-001645-PIP01-14-M04
• Compliance opinion date:
  24/02/2023
• Compliance outcome:
  Positive

Decision

P/0135/2022 : EMA decision of 13 April 2022 on the acceptance of a modification of an agreed paediatric investigation plan for bezlotoxumab (Zinplava), (EMEA-001645-PIP01-14-M04)

Adopted Reference Number: EMA/194322/2022