EMA/PE/0000221583 - paediatric investigation plan

famtozinameran

riltozinameran

tozinameran

Key facts

• Invented name:
  Comirnaty
• Active substance:
  • famtozinameran
  • riltozinameran
  • tozinameran
• Therapeutic area:
  Infections and infestations
• Decision number:
  EMA/PE/0000221583
• PIP number:
  EMA/PE/0000221583
• Pharmaceutical form(s):
  • Concentrate for dispersion for injection
  • Dispersion for injection
• Condition(s) / indication(s):
  Prevention of Coronavirus disease 2019 (COVID-19)
• Route(s) of administration:
  Intramuscular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/01/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000221583 : EMA decision of 8 January 2025 on the acceptance of a modification of an agreed paediatric investigation plan for famtozinameran, riltozinameran, tozinameran (Comirnaty)

Adopted Reference Number: EMADOC-1700519818-1834650