MHRA-100966-PIP01-23-M02 (update)

Key Facts

Active Substance
  • SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion homodimer - Omicron LP.8.1-LP.8.1 variant
  • selvacovatein
  • damlecovatein
Invented Name
  • BIMERVAX, BIMERVAX XBB.1.16, BIMERVAX LP.8.1
  • Bimervax
  • Bimervax
  • BIMERVAX
  • BIMERVAX
  • BIMERVAX XBB.1.16
  • BIMERVAX XBB.1.16
  • BIMERVAX XBB.1.16
  • BIMERVAX LP.8.1
  • BIMERVAX LP.8.1
  • BIMERVAX LP.8.1
  • Bimervax
  • BIMERVAX XBB.1.16
  • BIMERVAX LP.8.1
PIP Number MHRA-100966-PIP01-23-M02 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Emulsion for injection
Therapeutic area
Therapeutic area:
  • 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
Yes
Compliance Check Decision Date
Compliance Check Procedure Number
Compliance procedure number
MHRA-100966-PIP01-23-M02-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion homodimer - Omicron LP.8.1-LP.8.1 variantselvacovateindamlecovatein.pdf
Published Date 10/04/2026