EMEA-003115-PIP01-21 - paediatric investigation plan

Recombinant COVID-19 subunit nanoparticle (adjuvanted with AS03) (GBP510)

Key facts

• Active Substance:
  Recombinant COVID-19 subunit nanoparticle (adjuvanted with AS03) (GBP510)
• Therapeutic area:
  Vaccines
• Decision number:
  P/0261/2022
• PIP number:
  EMEA-003115-PIP01-21
• Pharmaceutical form(s):
  Emulsion and suspension for emulsion for injection
• Condition(s) / indication(s):
  Prevention of Coronavirus disease 2019 (COVID-19)
• Route(s) of administration:
  Intramuscular use
• Contact for public enquiries:

  SK Chemicals GmBH

  [e-mail]; [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  15/07/2022

Decision

P/0261/2022: EMA decision of 15 July 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral for recombinant COVID-19 subunit nanoparticle (adjuvanted with AS03) (GBP510) (EMEA-003115-PIP01-21)

AdoptedReference Number: EMA/629584/2022