EMEA-003191-PIP01-22-M01 - paediatric investigation plan

SARS-CoV-2 virus recombinant spike protein receptor binding domain fusion homodimer - XBB.1.16-XBB.1.16 variant

SARS-CoV-2 virus recombinant spike protein receptor binding domain fusion heterodimer (B.1.351 and B.1.1.7 strains) (beta-alpha variants)

Key facts

• Invented name:
  Bimervax
• Active Substance:
  • SARS-CoV-2 virus recombinant spike protein receptor binding domain fusion homodimer - XBB.1.16-XBB.1.16 variant
  • SARS-CoV-2 virus recombinant spike protein receptor binding domain fusion heterodimer (B.1.351 and B.1.1.7 strains) (beta-alpha variants)
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0253/2024
• PIP number:
  EMEA-003191-PIP01-22-M01
• Pharmaceutical form(s):
  Emulsion for injection
• Condition(s) / indication(s):
  Prevention of Coronavirus disease 2019 (COVID-19)
• Route(s) of administration:
  Intramuscular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  19/07/2024

Decision

P/0253/2024: EMA decision of 19 July 2024 on acceptance of a modification of an agreed PIP for SARS-CoV-2 virus recombinant spike protein receptor binding domain fusion homodimer ... (Bimervax), (EMEA-003191-PIP01-22-M01)

AdoptedReference Number: EMA/296812/2024