Dengvaxia
Withdrawn
This medicine's authorisation has been withdrawn
dengue tetravalent vaccine (live, attenuated)
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
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.
Product information
Latest procedure affecting product information:T/0033
12/12/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
VaccinesTherapeutic 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.
News on Dengvaxia
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