EMA/PE/0000225778 - paediatric investigation plan

sipavibart

Key facts

• Invented name:
  Kavigale
• Active substance:
  sipavibart
• Therapeutic area:
  Surgical and medical procedures
• Decision number:
  P/0504/2023
• PIP number:
  EMA/PE/0000225778
• Pharmaceutical form(s):
  • Solution for injection
  • Solution for infusion
• Condition(s) / indication(s):
  Prevention of Coronavirus disease 2019 (COVID-19)
• Route(s) of administration:
  • Intramuscular use
  • Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  20/03/2025
• Compliance check done:
  No

Decision

EMA/PE/0000225778: EMA decision of 20 March 2025 on the acceptance of a modification of an agreed paediatric investigation plan for sipavibart (Kavigale)

Adopted Reference Number: EMADOC-1700519818-1976387