MHRA-101641-PIP01-24

Key Facts

Active Substance
Active Substance:
  • Japanese encephalitis virus, strain SA14-14-2, Live
Invented Name
  • IMOJEV
  • IMOJEV
  • IMOJEV
PIP Number MHRA-101641-PIP01-24
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder and solvent for suspension for injection
Therapeutic area
  • Infectious diseases
  • Vaccines
Conditions / Indications
Conditions / Indications:
  • Prevention of Japanese encephalitis
Route(s) of administration
Route(s) of administration:
  • Subcutaneous use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
22/12/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-101641-PIP01-24 -C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Japanese encephalitis virus, strain SA14-14-2, Live.pdf
Published Date 16/07/2026