EMEA-002861-PIP02-20-M06 - paediatric investigation plan

Tozinameran

Tozinameran / famtozinameran

Key facts

• Invented name:
  Comirnaty
• Active Substance:
  • Tozinameran
  • Tozinameran / famtozinameran
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0393/2023
• PIP number:
  EMEA-002861-PIP02-20-M06
• Pharmaceutical form(s):
  • Concentrate for dispersion for injection
  • Dispersion for injection
• Condition(s) / indication(s):
  SARS-CoV-2 (COVID-19) infection prevention
• Route(s) of administration:
  Intramuscular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  28/09/2023

Decision

P/0393/2023: EMA decision of 28 September 2023 on the acceptance of a modification of an agreed paediatric investigation plan for tozinameran, tozinameran / famtozinameran (Comirnaty), (EMEA-002861-PIP02-20-M06)

AdoptedReference Number: EMA/424284/2023