Zabdeno

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ebola vaccine (Ad26.ZEBOV-GP [recombinant])

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

Overview

Zabdeno 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 Mvabea as part of a vaccine regimen.

Zabdeno contains a virus known as adenovirus which has been modified to allow the production of a protein from Zaire ebolavirus. The adenovirus itself has no effect on humans. Zabdeno only contains a small part of Zaire ebolavirus and cannot cause Ebola virus disease.

This EPAR was last updated on 23/07/2020

Authorisation details

Product details
Name
Zabdeno
Agency product number
EMEA/H/C/005337
Active substance
Recombinant Adenovirus type 26 (Ad26) encoding the glycoprotein (GP) of the Ebola virus Zaire (ZEBOV) Mayinga strain
International non-proprietary name (INN) or common name
ebola vaccine (Ad26.ZEBOV-GP [recombinant])
Therapeutic area (MeSH)
Hemorrhagic Fever, Ebola
Anatomical therapeutic chemical (ATC) code
J07
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 Zabdeno - EMEA/H/C/005337 -

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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