MHRA-100913-PIP01-23

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
  • mRNA that encodes for the NTD and RBD epitopes of the spike glycoprotein of SARS-CoV-2 (mRNA-1283)
Invented Name
Not available at present
PIP Number MHRA-100913-PIP01-23
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Suspension for injection
Therapeutic area
  • Infectious diseases
  • Vaccines
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
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):mRNA that encodes for the NTD and RBD epitopes of the spike glycoprotein of SARS-CoV-2 (mRNA-1283).pdf
Published Date 30/04/2024