EMEA-000669-PIP01-09-M02 - paediatric investigation plan

split influenza virus, inactivated containing antigen equivalent to A/California/7/2009 (H1N1)-like strain (A/California/7/2009 (NYMC X-179A)), adjuvanted

Key facts

• Invented name:
  • Humenza
  • Humenza
• Active substance:
  split influenza virus, inactivated containing antigen equivalent to A/California/7/2009 (H1N1)-like strain (A/California/7/2009 (NYMC X-179A)), adjuvanted
• Therapeutic area:
  Vaccines
• Decision number:
  P/0022/2019
• PIP number:
  EMEA-000669-PIP01-09-M02
• Pharmaceutical form(s):
  Suspension and emulsion for injection
• Condition(s) / indication(s):
  Prevention of influenza
• Route(s) of administration:
  Intramuscular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  04/01/2019
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000669-PIP01-09-M02
• Compliance opinion date:
  26/04/2019
• Compliance outcome:
  Positive

Decision

P/0022/2019: EMA decision of 4 January 2019 on the acceptance of a modification of an agreed paediatric investigation plan for split influenza virus, inactivated containing antigen equivalent to A/California/7/2009(H1N1)-like strain (A/California/7/2009 (

Adopted Reference Number: EMA/895159/2018