EMEA-002869-PIP03-21 - paediatric investigation plan

Influenza virus A/turkey/Turkey/1/2005 (H5N1) NIBRG-23 strain, HA surface antigen

Key facts

• Active substance:
  Influenza virus A/turkey/Turkey/1/2005 (H5N1) NIBRG-23 strain, HA surface antigen
• Therapeutic area:
  Vaccines
• Decision number:
  P/0141/2022
• PIP number:
  EMEA-002869-PIP03-21
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Prevention of zoonotic 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
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-002869-PIP03-21
• Compliance opinion date:
  09/09/2022
• Compliance outcome:
  Positive

Decision

P/0141/2022 : EMA decision of 13 April 2022 on the agreement of a paediatric investigation plan and on the granting of a waiver for influenza virus A/turkey/Turkey/1/2005 (H5N1) NIBRG-23 strain, HA surface antigen (EMEA-002869-PIP03-21)

Adopted Reference Number: EMA/197429/2022 Corr