MHRA-100391-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • TOZINAMERAN
Invented Name
  • Comirnaty
  • Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty 30 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
PIP Number MHRA-100391-PIP01-21-M01 (update)
Pharmaceutical form(s)
  • Concentrate for dispersion for injection
  • Dispersion for injection
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
Conditions / Indications:
  • Prevention of coronavirus disease 2019 (COVID-19)
Route(s) of administration
Route(s) of administration:
  • Intramuscular use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):TOZINAMERAN.pdf
Published Date 27/04/2022