MHRA-101643-PIP01-24

Key Facts

Active Substance
Active Substance:
  • Trivalent mRNA vaccine encoding for NoV VP1 (mRNA-1403)
Invented Name
Not yet available
PIP Number MHRA-101643-PIP01-24
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Dispersion for injection
Therapeutic area
Therapeutic area:
  • Vaccines
Conditions / Indications
Conditions / Indications:
  • Prevention of acute norovirus gastroenteritis.
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

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Trivalent mRNA vaccine encoding for NoV VP1 (mRNA-1403).pdf
Published Date 28/01/2026