MHRA-101097-PIP01-23-M01 (update)

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
  • Modified Vaccinia Ankara - Bavarian Nordic virus (smallpox)
Invented Name
  • Imvanex
  • Imvanex
  • Imvamune
  • Jynneos
  • Imvanex
PIP Number MHRA-101097-PIP01-23-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Suspension for injection
Therapeutic area
Therapeutic area:
  • Vaccines
Conditions / Indications
Conditions / Indications:
  • Prevention of smallpox, mpox and related orthopoxvirus infection and disease
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
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Modified Vaccinia Ankara - Bavarian Nordic virus (smallpox).pdf
Published Date 24/06/2024