EMEA-002861-PIP02-20-M07 - paediatric investigation plan

tozinameran

raxtozinameran

Key facts

• Invented name:
  Comirnaty
• Active substance:
  • tozinameran
  • raxtozinameran
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0105/2024
• PIP number:
  EMEA-002861-PIP02-20-M07
• 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:
  12/04/2024
• Compliance check done:
  No

Decision

P/0105/2024: EMA decision of 12 April 2024 on the acceptance of a modification of an agreed paediatric investigation plan for tozinameran, tozinameran / famtozinameran, tozinameran/ riltozinameran, raxtozinameran (Comirnaty), (EMEA-002861-PIP02-20-M07)

Adopted Reference Number: EMA/99159/2024