EMEA-003346-PIP01-22 - paediatric investigation plan

single-stranded 5' capped mRNA encoding the HAs of the influenza virus strains A and B (mRNA-1010)

Key facts

• Active substance:
  single-stranded 5' capped mRNA encoding the HAs of the influenza virus strains A and B (mRNA-1010)
• Therapeutic area:
  Vaccines
• Decision number:
  P/0327/2023
• PIP number:
  EMEA-003346-PIP01-22
• Pharmaceutical form(s):
  Dispersion for injection
• Condition(s) / indication(s):
  Prevention of influenza
• 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:
  08/08/2023
• Compliance check done:
  No

Decision

P/0327/2023 : EMA decision of 8 Aug 2023 on agreement of a PIP and on the granting of a deferral and on the granting of a waiver for single-stranded 5' capped mRNA encoding the HAs of the influenza virus strains A and B (mRNA-1010), (EMEA-003346-PIP01-22)

Reference Number: EMA/343305/2023