Imvanex - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

smallpox and monkeypox vaccine (Live Modified Vaccinia Virus Ankara)

Opinion

On 25 June 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Imvanex. The marketing authorisation holder for this medicinal product is Bavarian Nordic A/S.

The CHMP adopted an extension to an existing indication, as follows:

Active immunisation against smallpox, monkeypox and disease caused by vaccinia virus in individuals 212 years of age and older (see sections 4.4 and 5.1).

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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Notes: New text in bold, removed text as strikethrough.

CHMP post-authorisation summary of positive opinion for Imvanex (VR-0000337204)

Adopted Reference Number: Imvanex

Key facts

• Name of medicine:
  Imvanex
• EMA product number:
  EMEA/H/C/002596
• Active substance:
  modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus
• International non-proprietary name (INN) or common name:
  smallpox and monkeypox vaccine (Live Modified Vaccinia Virus Ankara)
• Therapeutic area (MeSH):
  • Smallpox Vaccine
  • Monkeypox virus
• Anatomical therapeutical chemical (ATC) code:
  J07BX
• Additional monitoring:

  This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

• Exceptional circumstances:

  This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

• Marketing authorisation holder:
  Bavarian Nordic A/S
• Date of opinion:
  25/06/2026
• Status:
  Positive