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

Tozinameran
Tozinameran / famtozinameran
tozinameran/ riltozinameran
raxtozinameran
PIPHuman

Key facts

Invented name
Comirnaty
Active Substance
  • Tozinameran
  • Tozinameran / famtozinameran
  • tozinameran/ riltozinameran
  • 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
Contact for public enquiries

BioNTech Manufacturing GmbH 
Tel.  +49 613190847507 
E-mail: Constanze.Blume.Comirnaty@biontech.de

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date

Decision

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