EMEA-003349-PIP01-22 - paediatric investigation plan

zapomeran

Key facts

• Active substance:
  zapomeran
• Therapeutic area:
  Vaccines
• Decision number:
  P/0204/2023
• PIP number:
  EMEA-003349-PIP01-22
• Pharmaceutical form(s):
  Powder for dispersion for injection
• Condition(s) / indication(s):
  Prevention of Coronavirus disease 2019 (COVID-19)
• Route(s) of administration:
  Intramuscular use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  05/06/2023
• Compliance check done:
  No

Decision

P/0204/2023 : EMA decision of 5 June 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral for zapomeran (EMEA-003349-PIP01-22)

Reference Number: EMA/245863/2023