MHRA-101097-PIP01-23-M02 (update)

Key Facts

Active Substance
Active Substance:
  • Modified Vaccinia Ankara – Bavarian Nordic Live virus
Invented Name
  • Imvanex
  • Imvamune
  • Imvanex
  • Imvanex
  • Jynneos
  • Jynneos
  • Jynneos
  • Jynneos
  • IMVANEX (associated names: JYNNEOS, IMVAMUNE)
PIP Number MHRA-101097-PIP01-23-M02 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Suspension for injection
Therapeutic area
  • Infectious diseases
  • Vaccines
Conditions / Indications
Conditions / Indications:
  • Prevention of smallpox, mpox and diseases caused by vaccinia virus
Route(s) of administration
Route(s) of administration:
  • Subcutaneous use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
02/10/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-101097-PIP01-23-M02-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Modified Vaccinia Ankara ? Bavarian Nordic Live virus.pdf
Published Date 14/10/2026