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 in people aged 6 to 45 years who have had a previous dengue virus infection.

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

This EPAR was last updated on 26/01/2022

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
3
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

09/12/2021 Dengvaxia - EMEA/H/C/004171 - II/0011

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Product information documents contain:

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

Dengvaxia is indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 6 to 45 years of age with test-confirmed previous dengue infection (see sections 4.2, 4.4 and 4.8).

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

Assessment history

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