EMEA-000687-PIP01-09-M02 - paediatric investigation plan

Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted), containing antigen equivalent to Influenza A/California/7/2009

Key facts

• Invented name:
  • Arepanrix
  • Arepanrix
• Active substance:
  Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted), containing antigen equivalent to Influenza A/California/7/2009
• Therapeutic area:
  Vaccines
• Decision number:
  P/148/2010
• PIP number:
  EMEA-000687-PIP01-09-M02
• Pharmaceutical form(s):
  Suspension and emulsion for emulsion for injection
• Condition(s) / indication(s):
  Influenza
• Route(s) of administration:
  Intramuscular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  09/08/2010
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000687-PIP01-09-M02
• Compliance opinion date:
  12/12/2014
• Compliance outcome:
  Positive

Decision

P/148/2010: EMA decision of 3 August 2010 on the acceptance of a modification of an agreed paediatric investigation plan for pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted), containing antigen e...

Adopted Reference Number: EMA/425529/2010