Ervebo

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Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live)

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

Overview

Ervebo is a vaccine to protect adults aged 18 years 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 Zaire Ebola virus and cannot cause the disease.

This EPAR was last updated on 12/12/2019

Authorisation details

Product details
Name
Ervebo
Agency product number
EMEA/H/C/004554
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
International non-proprietary name (INN) or common name
Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live)
Therapeutic area (MeSH)
Hemorrhagic Fever, Ebola
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.

Conditional approvalConditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

Publication details
Marketing-authorisation holder
Merck Sharp & Dohme B.V. 
Date of issue of marketing authorisation valid throughout the European Union
11/11/2019
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

11/11/2019 Ervebo - EMEA/H/C/004554 -

Contents

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Pharmacotherapeutic group

Vaccines

Therapeutic indication

Ervebo is indicated for active immunization of individuals 18 years of age or older to protect against Ebola Virus Disease (EVD) caused by Zaire Ebola virus (see sections 4.2, 4.4 and 5.1).

The use of Ervebo should be in accordance with official recommendations.

Assessment history

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