MHRA-100966-PIP01-23-M01 (update)

Key Facts

Active Substance
  • Selvacovatein (INN) - SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer (B.1.351 and B.1.1.7 strains) (beta-alpha variants)
  • SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion homodimer – XBB.1.16-XBB.1.16 variant
Invented Name
  • Bimervax
  • Bimervax
  • Bimervax
  • Bimervax
  • BIMERVAX
  • BIMERVAX
PIP Number MHRA-100966-PIP01-23-M01 (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
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Selvacovatein (INN) - SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer (B.1.351 and B.1.1.7 strains) (beta-alpha variants)SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion homodimer ? XBB.1.16-XBB.1.16 variant.pdf
Published Date 06/01/2025