Mvabea

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Ebola vaccine (rDNA, replication-incompetent)

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

Overview

Mvabea is a vaccine to protect adults and children aged one year and older against Ebola virus disease caused by Zaire ebolavirus. It is used with another Ebola vaccine called Zabdeno as part of a vaccine regimen.

Mvabea contains a virus known as Vaccinia Ankara Bavarian Nordic which has been modified to produce 4 proteins from Zaire ebolavirus and three other viruses of the same group (filoviridae). The modified vaccinia Ankara Bavarian Nordic virus itself has no effect on humans. Mvabea only contains parts of the viruses and cannot cause Ebola virus disease.

This EPAR was last updated on 23/07/2020

Authorisation details

Product details
Name
Mvabea
Agency product number
EMEA/H/C/005343
Active substance
Recombinant Modified Vaccinia Ankara Bavarian Nordic Virus encoding the: Ebola virus Zaire (ZEBOV) Mayinga strain glycoprotein (GP); Ebola virus Sudan Gulu strain GP; Ebola virus Taï Forest strain nucleoprotein and the Marburg virus Musoke strain GP
International non-proprietary name (INN) or common name
Ebola vaccine (rDNA, replication-incompetent)
Therapeutic area (MeSH)
Hemorrhagic Fever, Ebola
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
Janssen-Cilag International N.V.   
Date of issue of marketing authorisation valid throughout the European Union
01/07/2020
Contact address

Turnhoutseweg 30
BE-2340 Beerse
Belgium

Product information

01/07/2020 Mvabea - EMEA/H/C/005343 -

Contents

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Pharmacotherapeutic group

Vaccines

Therapeutic indication

Active immunization for prevention of disease caused by Ebola virus (Zaire Ebolavirus species) in individuals ≥ 1 year of age.

Assessment history

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