Ervebo
Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live)
Table of contents
Overview
Ervebo is a vaccine to protect adults and children aged 1 year and older against Ebola virus disease caused by the Zaire Ebola virus.
Ervebo contains a virus known as vesicular stomatitis virus which has been weakened and modified to contain a protein from the Zaire Ebola virus. The vesicular stomatitis virus itself has little or no effect on humans. The vaccine only contains one protein from the Zaire Ebola virus and cannot cause Ebola virus disease.
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Ervebo : EPAR - Medicine overview (PDF/149.82 KB)
First published: 12/12/2019
Last updated: 22/08/2023
EMA/344888/2023 -
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Ervebo : EPAR - Risk-management-plan summary (PDF/99.58 KB)
First published: 12/12/2019
Last updated: 22/08/2023
Authorisation details
Product details | |
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Name |
Ervebo
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Agency product number |
EMEA/H/C/004554
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Active substance |
recombinant vesicular stomatitis virus (strain indiana) with a deletion of the envelope glycoprotein, replaced with the zaire ebolavirus (strain kikwit 1995) surface glycoprotein
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International non-proprietary name (INN) or common name |
Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live)
|
Therapeutic area (MeSH) |
Hemorrhagic Fever, Ebola
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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. |
Publication details | |
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Marketing-authorisation holder |
Merck Sharp & Dohme B.V.
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Revision |
8
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Date of issue of marketing authorisation valid throughout the European Union |
11/11/2019
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Contact address |
Waarderweg 39 |
Product information
16/08/2023 Ervebo - EMEA/H/C/004554 - II/0025
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Vaccines
Therapeutic indication
Ervebo is indicated for active immunization of individuals 1 year of age or older to protect against Ebola Virus Disease (EVD) caused by Zaire Ebola virus.
The use of Ervebo should be in accordance with official recommendations.