Imvanex

RSS

modified vaccinia Ankara virus

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

Overview

This is a summary of the European public assessment report (EPAR) for Imvanex. It explains how the European Medicines Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Imvanex.

For practical information about using Imvanex, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 18/05/2018

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
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
Marketing-authorisation holder
Bavarian Nordic A/S
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
31/07/2013
Contact address
Hejreskovvej 10 A
Kvistgård, 3490
Denmark

Product information

23/04/2018 Imvanex - EMEA/H/C/002596 - IB/0033

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Other viral vaccines

Therapeutic indication

Active immunisation against smallpox infection and disease in adults.

Assessment history

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