Dengvaxia

dengue tetravalent vaccine (live, attenuated)

Table of contents

Opinion

On 11 November 2021, the Committee for Medicinal Products for Human Use (CHMP) recommended changes to the terms of the marketing authorisation for the medicinal product Dengvaxia. The marketing authorisation holder for this medicinal product is Sanofi Pasteur.

The CHMP adopted a new indication as follows:1

Dengvaxia is indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 9  6 to 45 years of age with test-confirmed previous dengue infection prior dengue virus infection and living in endemic areas.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after the respective decisions on these changes to the marketing authorisation have been granted by the European Commission.


1 New text in bold, removed text as strikethrough.

Key facts

Name
Dengvaxia
Agency product number
EMEA/H/C/004171
International non-proprietary name (INN) or common name
  • dengue tetravalent vaccine (live, attenuated)
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)
Therapeutic area
Dengue
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.

Date opinion adopted
11/11/2021
Company name
Sanofi Pasteur
Status
Positive
Application type
Post-authorisation

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