MHRA-100601-PIP01-22-M01 (update)

Key Facts

PIPS Key Facts
Active Substance
  • elasomeran
  • imelasomeran
Invented Name
  • Spikevax bivalent Original / Omicron
  • Spikevax
PIP Number MHRA-100601-PIP01-22-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Dispersion 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
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):elasomeranimelasomeran.pdf
Published Date 07/12/2022