EMEA-002869-PIP01-21 - paediatric investigation plan

Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/H5N1

Key facts

• Active Substance:
  Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/H5N1
• Therapeutic area:
  Vaccines
• Decision number:
  P/0144/2022
• PIP number:
  EMEA-002869-PIP01-21
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Prevention of pandemic 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:
  13/04/2022

Decision

P/0144/2022 : EMA decision of 13 April 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral for influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/H5N1 (EMEA-002869-PIP01-21)

Reference Number: EMA/194390/2022