EMEA-000559-PIP01-09-M04 - paediatric investigation plan

Japanese encephalitis virus, inactivated (attenuated strain SA14-14-2 grown in vero cells)

Key facts

• Invented name:
  • Ixiaro
  • Ixiaro
• Active substance:
  Japanese encephalitis virus, inactivated (attenuated strain SA14-14-2 grown in vero cells)
• Therapeutic area:
  Vaccines
• Decision number:
  P/0278/2017
• PIP number:
  EMEA-000559-PIP01-09-M04
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Prevention of Japanese encephalitis
• Route(s) of administration:
  Intramuscular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  04/10/2017
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000559-PIP01-09-M04
• Compliance opinion date:
  10/11/2017
• Compliance outcome:
  Positive

Decision

P/0278/2017: EMA decision of 4 October 2017 on the acceptance of a modification of an agreed paediatric investigation plan for Japanese encephalitis vaccine (inactivated, adsorbed) (Ixiaro) (EMEA-000559-PIP01-09-M04)

Reference Number: EMA/574564/2017