EMEA-001161-PIP02-11-M03 - paediatric investigation plan

Modified Vaccinia Ankara - Bavarian Nordic virus (smallpox)

Key facts

• Invented name:
  Imvanex
• Active substance:
  Modified Vaccinia Ankara - Bavarian Nordic virus (smallpox)
• Therapeutic area:
  Vaccines
• Decision number:
  EMA/PE/0000223819
• PIP number:
  EMEA-001161-PIP02-11-M03
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Prevention of smallpox, monkeypox and related orthopoxvirus infection and disease
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  28/01/2025
• Compliance check done:
  Nej

Decision

EMA/PE/0000223819 : EMA decision of 28 January 2025 on the acceptance of a modification of an agreed paediatric investigation plan for modified vaccinia Ankara – bavarian nordic live virus (Imvanex)

Adopted Reference Number: EMADOC-1700519818-1852052