smallpox vaccine (Live Modified Vaccinia Virus Ankara)

This medicine is authorised for use in the European Union.


Imvanex is a vaccine used to protect against smallpox in adults. It contains a live modified form of the vaccinia virus called ‘vaccinia Ankara’, which is related to the smallpox virus.

Smallpox was officially declared eradicated in 1980 with the last known case of the disease occurring in 1977. This vaccine will be used when it is considered necessary to protect against smallpox in accordance with official recommendations.

This EPAR was last updated on 14/12/2020

Authorisation details

Product details
Agency product number
Active substance
modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus
International non-proprietary name (INN) or common name
smallpox vaccine (Live Modified Vaccinia Virus Ankara)
Therapeutic area (MeSH)
Smallpox Vaccine
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional 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 circumstancesExceptional 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.

Publication details
Marketing-authorisation holder
Bavarian Nordic A/S
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Hejreskovvej 10 A
Kvistgård, 3490

Product information

18/11/2020 Imvanex - EMEA/H/C/002596 - IAIN/0059/G


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Pharmacotherapeutic group

Other viral vaccines

Therapeutic indication

Active immunisation against smallpox infection and disease in adults.

Assessment history

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