Zabdeno
Ebola vaccine (rDNA, replication-incompetent)
Table of contents
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.
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Zabdeno : EPAR - Medicine overview (PDF/127.3 KB)
First published: 23/07/2020
EMA/298997/2020 -
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Zabdeno : EPAR - Risk-management-plan summary (PDF/143.31 KB)
First published: 23/07/2020
Authorisation details
Product details | |
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Name |
Zabdeno
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Agency product number |
EMEA/H/C/005337
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Active substance |
Recombinant Adenovirus type 26 (Ad26) encoding the glycoprotein (GP) of the Ebola virus Zaire (ZEBOV) Mayinga strain
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International non-proprietary name (INN) or common name |
Ebola vaccine (rDNA, replication-incompetent)
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Therapeutic area (MeSH) |
Hemorrhagic Fever, Ebola
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Anatomical therapeutic chemical (ATC) code |
J07
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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 |
Janssen-Cilag International N.V.
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Date of issue of marketing authorisation valid throughout the European Union |
01/07/2020
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Contact address |
Product information
01/07/2020 Zabdeno - EMEA/H/C/005337 -
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
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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.