EMEA-000124-PIP01-07-M02 - paediatric investigation plan

Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains: A/Solomon Islands/3/2006 (H1N1)-like strain (A/Solomon Islands/3/2006, IVR-145); A/Wisconsin/67/2005 (H3N2)-like strain (A/Wisconsin/67/2005, NYMC X161B); B/Malaysia/2506/2004-like strain (B/Malaysia/2506/2004)

Key facts

• Invented name:
  • Optaflu
  • Optaflu
• Active substance:
  Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains: A/Solomon Islands/3/2006 (H1N1)-like strain (A/Solomon Islands/3/2006, IVR-145); A/Wisconsin/67/2005 (H3N2)-like strain (A/Wisconsin/67/2005, NYMC X161B); B/Malaysia/2506/2004-like strain (B/Malaysia/2506/2004)
• Therapeutic area:
  Vaccines
• Decision number:
  P/0210/2012
• PIP number:
  EMEA-000124-PIP01-07-M02
• Pharmaceutical form(s):
  Suspension for injection in pre-filled syringe
• 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:
  28/09/2012
• Compliance check done:
  No

Decision

P/0210/2012: EMA decision of 28 September 2012 on the acceptance of a modification of an agreed paediatric investigation plan for influenza virus surface antigens (haemagglutinin (HA) and neuraminidase) (EMEA-000124-PIP...

Adopted Reference Number: EMA/501330/2012