Imvanex

RSS

modified vaccinia Ankara virus

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 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 28/08/2019

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
modified vaccinia Ankara virus
Therapeutic area (MeSH)
Smallpox Vaccine
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
14
Date of issue of marketing authorisation valid throughout the European Union
31/07/2013
Contact address
Hejreskovvej 10 A
Kvistgård, 3490
Denmark

Product information

11/04/2019 Imvanex - EMEA/H/C/002596 - II/0036

Contents

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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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