EMEA-002861-PIP02-20-M05 - paediatric investigation plan

Tozinameran

Key facts

• Invented name:
  Comirnaty
• Active Substance:
  Tozinameran
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0466/2022
• PIP number:
  EMEA-002861-PIP02-20-M05
• 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
• Contact for public enquiries:

  BioNTech Manufacturing GmbH

  Email: [e-mail] ; Tel. [phone];

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  31/12/2021

Decision

P/0466/2022 : EMA decision of 7 November 2022 on the acceptance of a modification of an agreed paediatric investigation plan for tozinameran, tozinameran / famtozinameran (Comirnaty) (EMEA-002861-PIP02-20-M05)

Reference Number: EMA/864103/2022