EMEA-001161-PIP02-11-M02 - 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:
  P/0539/2022
• PIP number:
  EMEA-001161-PIP02-11-M02
• 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
• Contact for public enquiries:

  Bavarian Nordic A/S

  E-mail: [e-mail]

  Tel. [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/12/2022

Decision

P/0539/2022 : EMA decision of 30 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for modified Vaccinia Ankara - Bavarian Nordic virus (smallpox) (Imvanex) (EMEA-001161-PIP02-11-M02)

AdoptedReference Number: EMA/876000/2022