EMEA-002234-PIP01-17-M02 - paediatric investigation plan

purified inactivated rabies virus (WISTAR PM/WI 38-1503-3M strain)

Key facts

• Active substance:
  purified inactivated rabies virus (WISTAR PM/WI 38-1503-3M strain)
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0051/2024
• PIP number:
  EMEA-002234-PIP01-17-M02
• Pharmaceutical form(s):
  Powder and solvent for suspension for injection
• Condition(s) / indication(s):
  Prevention of rabies viral infection
• Route(s) of administration:
  • Intramuscular use
  • Intradermal use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/03/2024
• Compliance check done:
  Yes
• Compliance procedure number:
  EMA/PE/0000227887
• Compliance opinion date:
  13/12/2024
• Compliance outcome:
  Positive

Decision

P/0051/2024 : EMA decision of 8 March 2024 on the acceptance of a modification of an agreed paediatric investigation plan for purified inactivated rabies virus (WISTAR PM/WI 38-1503-3M strain) (EMEA-002234-PIP01-17-M02)

Adopted Reference Number: EMA/53565/2024