EMEA-003191-PIP01-22 - paediatric investigation plan

SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer – B.1.351-B.1.1.7 strains

Key facts

• Invented name:
  Bimervax
• Active Substance:
  SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer – B.1.351-B.1.1.7 strains
• Therapeutic area:
  • Infectious diseases
  • Vaccines
• Decision number:
  P/0465/2022
• PIP number:
  EMEA-003191-PIP01-22
• Pharmaceutical form(s):
  Emulsion for injection
• Condition(s) / indication(s):
  Prevention of Coronavirus disease 2019 (COVID-19)
• Route(s) of administration:
  Intramuscular use
• Contact for public enquiries:

  HIPRA Human Health S.L.U.

  Email: [e-mail]

  Tel. [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  04/11/2022

Decision

P/0465/2022: EMA decision of 4 November 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral for COVID-19 Vaccine (recombinant, adjuvanted) (EMEA-003191-PIP01-22)

AdoptedReference Number: EMA/853635/2022