EMEA-000725-PIP01-09-M03 - paediatric investigation plan

split influenza virus, inactivated, containing antigen: A/California/7/2009 (H1N1)v like strain (X-179A)

Key facts

• Invented name:
  • Pandemrix
  • Pandemrix
• Active substance:
  split influenza virus, inactivated, containing antigen: A/California/7/2009 (H1N1)v like strain (X-179A)
• Therapeutic area:
  Vaccines
• Decision number:
  P228/2011
• PIP number:
  EMEA-000725-PIP01-09-M03
• Pharmaceutical form(s):
  Suspension and 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:
  29/09/2011
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-000725-PIP01-09-M03
• Compliance opinion date:
  12/12/2014
• Compliance outcome:
  Positive

Decision

P/228/2011: EMA decision of 28 September 2011 on the acceptance of a modification of an agreed paediatric investigation plan for split Influenza virus, inactivated, containing antigen: A/California/7/2009 (H1N1)v like s...

Adopted Reference Number: EMA/698108/2011