Dengvaxia

Withdrawn

This medicine's authorisation has been withdrawn

dengue tetravalent vaccine (live, attenuated)

Overview

On 21 October 2025, the European Commission withdrew the marketing authorisation for Dengvaxia (dengue tetravalent vaccine (live, attenuated)) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Sanofi Winthrop Industrie, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.

Dengvaxia was granted marketing authorisation in the EU on 12 December 2018 for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2023.

 

Dengvaxia : EPAR - Medicine overview

Reference Number: EMA/688282/2021

Dengvaxia : EPAR - Risk management plan summary

Product information

Dengvaxia : EPAR - Product information

Dengvaxia : EPAR - All authorised presentations

Product details

• Name of medicine:
  Dengvaxia
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/004171
• Marketing authorisation holder:
  Sanofi Winthrop Industrie

  82 Avenue Raspail ; 94250 Gentilly ; France

• Opinion adopted:
  17/10/2018
• Marketing authorisation issued:
  12/12/2018
• Withdrawal of marketing authorisation:
  21/10/2025
• Revision:
  7

Assessment history

Changes since initial authorisation of medicine

Dengvaxia : EPAR - Procedural steps taken and scientific information after authorisation

Dengvaxia-H-C-4171-II-12 : EPAR - Assessment report - Variation

Adopted Reference Number: EMA/754269/2021

Dengvaxia-H-C-4171-II-11 : EPAR - Assessment report - Variation

Adopted Reference Number: EMA/754271/2021

CHMP post-authorisation summary of positive opinion for Dengvaxia (II-11;II-12)

Adopted Reference Number: EMA/CHMP/618604/2021

Dengvaxia-H-C-4171-II-0003-G : EPAR - Assessment report - Variation

Adopted Reference Number: EMA/553606/2019

Initial marketing authorisation documents

Dengvaxia : EPAR - Public assessment report

Adopted Reference Number: EMA/791273/2018

CHMP summary of positive opinion for Dengvaxia

Adopted Reference Number: EMA/CHMP/666423/2018