MHRA-100392-PIP01-21-M07 (update)

Key Facts

Active Substance
Active Substance:
  • Highly purified single-stranded, 5’-capped mRNA encoding full-length SARS-CoV-2 spike protein (BNT162b2); Tozinameran; Famtozinameran; Riltozinameran; Raxtozinameran; Bretovameran Cemivameran; COVID-19 mRNA Vaccine
Invented Name
  • Comirnaty
  • Comirnaty 30 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty Original/Omicron BA.1 (15/15 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty 30 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine
  • Comirnaty Original/Omicron BA.4-5 15/15 micrograms per dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine
  • Comirnaty Original/Omicron BA.4-5 1.5/1.5 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine
  • Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine
  • Comirnaty Omicron XBB.1.5 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty Omicron XBB.1.5 10 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine
  • Comirnaty Omicron XBB.1.5 3 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty LP.8.1 10 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine
  • Comirnaty LP.8.1 3 micrograms/dose concentrate for dispersion for injection, 3-dose vial COVID-19 mRNA Vaccine
  • Comirnaty LP.8.1 30 micrograms/dose dispersion for injection in pre-filled syringe COVID-19 mRNA Vaccine
  • Comirnaty Omicron KP.2 3 micrograms/dose concentrate for dispersion for injection, 3-dose vial COVID-19 mRNA Vaccine
  • Comirnaty Omicron KP.2 10 micrograms/dose dispersion for injection, single dose vial, Comirnaty Omicron KP.2 10 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine
  • Comirnaty Omicron KP.2 10 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty Omicron KP.2 30 micrograms/dose dispersion for injection in pre-filled syringe COVID-19 mRNA Vaccine
  • Comirnaty Omicron KP.2 30 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine
  • Comirnaty Omicron JN.1 3 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty Omicron JN.1 3 micrograms/dose concentrate for dispersion for injection, COVID-19 mRNA Vaccine
  • Comirnaty Omicron JN.1 10 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine
  • Comirnaty Omicron JN.1 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty Omicron JN.1 10 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine
PIP Number MHRA-100392-PIP01-21-M07 (update)
Pharmaceutical form(s)
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:
  • Intravenous 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):Highly purified single-stranded, 5?-capped mRNA encoding full-length SARS-CoV-2 spike protein (BNT162b2) Tozinameran Famtozinameran Riltozinameran Raxtozinameran BretovameranCemivameran COV.pdf
Published Date 10/04/2026