Imvanex

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smallpox and monkeypox vaccine (Live Modified Vaccinia Virus Ankara)

Authorised
This medicine is authorised for use in the European Union.

Overview

Imvanex is a vaccine used to protect against smallpox in adults. It contains an attenuated (weakened) form of the vaccinia virus called ‘modified vaccinia virus 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.

Imvanex can also be used to protect adults from monkeypox and disease caused by the vaccinia virus.

This EPAR was last updated on 22/12/2022

Authorisation details

Product details
Name
Imvanex
Agency 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 therapeutic chemical (ATC) code
J07BX
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
Revision
23
Date of issue of marketing authorisation valid throughout the European Union
31/07/2013
Contact address
Hejreskovvej 10 A
Kvistgård, 3490
Denmark

Product information

22/12/2022 Imvanex - EMEA/H/C/002596 - N/0086

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Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Other viral vaccines

Therapeutic indication

Active immunisation against smallpox, monkeypox and disease caused by vaccinia virus in adults (see sections 4.4 and 5.1).

The use of this vaccine should be in accordance with official recommendations.

Assessment history

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