Dengvaxia

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dengue tetravalent vaccine (live, attenuated)

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

Overview

Dengvaxia is a vaccine used to help protect against dengue disease.

Dengue disease is a mosquito-borne tropical disease caused by the dengue virus leading to mild, flu-like symptoms in most people. However, a small number of patients develop severe disease, with potentially fatal bleeding and organ damage. The risk of severe disease is higher in people who have been infected a second time.

There are several varieties (called serotypes) of dengue virus and Dengvaxia protects against serotypes 1, 2, 3 and 4.

Dengvaxia is only for use in people from 9 to 45 years of age who have been infected with dengue virus before and who live in areas where this infection is endemic. Endemic areas are areas where the disease occurs regularly throughout the year.

Dengvaxia contains attenuated (weakened) yellow fever viruses that have been manipulated so that they contain proteins from dengue virus.

This EPAR was last updated on 23/10/2019

Authorisation details

Product details
Name
Dengvaxia
Agency product number
EMEA/H/C/004171
Active substance
chimeric yellow fever dengue virus serotype 1 (live, attenuated) / chimeric yellow fever dengue virus serotype 2 (live, attenuated) / chimeric yellow fever dengue virus serotype 3 (live, attenuated) / chimeric yellow fever dengue virus serotype 4 (live, attenuated)
International non-proprietary name (INN) or common name
dengue tetravalent vaccine (live, attenuated)
Therapeutic area (MeSH)
Dengue
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.

Publication details
Marketing-authorisation holder
Sanofi Pasteur
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
12/12/2018
Contact address

14 Espace Henry Vallée
69007 Lyon
France

Product information

19/09/2019 Dengvaxia - EMEA/H/C/004171 - II/0003/G

Contents

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Pharmacotherapeutic group

Vaccines

Therapeutic indication

Dengvaxia is indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 9 to 45 years of age with prior dengue virus infection and living in endemic areas.
The use of Dengvaxia should be in accordance with official recommendations.

Assessment history

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