Imvanex
smallpox and monkeypox vaccine (Live Modified Vaccinia Virus Ankara)
Table of contents
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.
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Imvanex : EPAR - Medicine overview (PDF/120.3 KB)
First published: 16/08/2013
Last updated: 25/07/2022 -
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Imvanex : EPAR - Risk-management-plan summary (PDF/1.41 MB)
First published: 27/05/2020
Last updated: 29/03/2023
Authorisation details
Product details | |
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Name |
Imvanex
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Agency product number |
EMEA/H/C/002596
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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) |
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Anatomical therapeutic 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. |
Publication details | |
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Marketing-authorisation holder |
Bavarian Nordic A/S
|
Revision |
25
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Date of issue of marketing authorisation valid throughout the European Union |
31/07/2013
|
Contact address |
Hejreskovvej 10 A
Kvistgård, 3490 Denmark |
Product information
16/03/2023 Imvanex - EMEA/H/C/002596 - II/0081
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.