Dengvaxia

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Withdrawn

This medicine's authorisation has been withdrawn

dengue tetravalent vaccine (live, attenuated)
MedicineHumanWithdrawn

Romanian is available via eTranslation, the European Commission's machine translation service.

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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.

 

Dengvaxia : EPAR - Medicine overview

Reference Number: EMA/688282/2021

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български (BG) (154.41 KB - PDF)

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eesti (ET) (112.98 KB - PDF)

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ελληνικά (EL) (181.92 KB - PDF)

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français (FR) (128.02 KB - PDF)

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hrvatski (HR) (173.59 KB - PDF)

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italiano (IT) (151.22 KB - PDF)

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latviešu (LV) (167.61 KB - PDF)

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magyar (HU) (184.27 KB - PDF)

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Malti (MT) (175.05 KB - PDF)

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Nederlands (NL) (152.86 KB - PDF)

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polski (PL) (189.68 KB - PDF)

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português (PT) (153.8 KB - PDF)

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română (RO) (172.62 KB - PDF)

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slovenčina (SK) (185.93 KB - PDF)

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slovenščina (SL) (181.96 KB - PDF)

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suomi (FI) (150.13 KB - PDF)

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svenska (SV) (151.01 KB - PDF)

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Dengvaxia : EPAR - Risk management plan summary

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Product information

Dengvaxia : EPAR - Product information

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български (BG) (715.74 KB - PDF)

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español (ES) (646.34 KB - PDF)

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čeština (CS) (601.1 KB - PDF)

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dansk (DA) (683.89 KB - PDF)

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Deutsch (DE) (575.08 KB - PDF)

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eesti (ET) (517.91 KB - PDF)

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ελληνικά (EL) (653.63 KB - PDF)

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français (FR) (644.24 KB - PDF)

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hrvatski (HR) (606.24 KB - PDF)

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italiano (IT) (754.23 KB - PDF)

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latviešu (LV) (591.91 KB - PDF)

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lietuvių (LT) (582.43 KB - PDF)

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magyar (HU) (676.82 KB - PDF)

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Malti (MT) (758.71 KB - PDF)

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Nederlands (NL) (718.88 KB - PDF)

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polski (PL) (675.72 KB - PDF)

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português (PT) (673.72 KB - PDF)

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română (RO) (635.25 KB - PDF)

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slovenčina (SK) (608.69 KB - PDF)

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slovenščina (SL) (606.99 KB - PDF)

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suomi (FI) (591.72 KB - PDF)

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svenska (SV) (522.48 KB - PDF)

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Íslenska (IS) (507.58 KB - PDF)

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Latest procedure affecting product information:T/0033
12/12/2024
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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).

Dengvaxia : EPAR - All authorised presentations

English (EN) (74.11 KB - PDF)

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български (BG) (83.43 KB - PDF)

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español (ES) (73.62 KB - PDF)

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čeština (CS) (78.96 KB - PDF)

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dansk (DA) (61.54 KB - PDF)

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Deutsch (DE) (60.45 KB - PDF)

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eesti (ET) (60.08 KB - PDF)

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ελληνικά (EL) (76.49 KB - PDF)

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français (FR) (60.03 KB - PDF)

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hrvatski (HR) (162.99 KB - PDF)

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italiano (IT) (59.02 KB - PDF)

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latviešu (LV) (78.98 KB - PDF)

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lietuvių (LT) (97.36 KB - PDF)

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magyar (HU) (94.31 KB - PDF)

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Malti (MT) (82.36 KB - PDF)

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Nederlands (NL) (60.55 KB - PDF)

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polski (PL) (82.4 KB - PDF)

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português (PT) (61.65 KB - PDF)

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română (RO) (76.71 KB - PDF)

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slovenčina (SK) (80.55 KB - PDF)

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slovenščina (SL) (87.49 KB - PDF)

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suomi (FI) (59.01 KB - PDF)

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svenska (SV) (59.89 KB - PDF)

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Íslenska (IS) (60.99 KB - PDF)

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norsk (NO) (59.91 KB - PDF)

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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

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

English (EN) (201.71 KB - PDF)

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

Adopted Reference Number: EMA/754269/2021

English (EN) (4.61 MB - PDF)

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

Adopted Reference Number: EMA/754271/2021

English (EN) (2.13 MB - PDF)

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

Adopted Reference Number: EMA/CHMP/618604/2021

English (EN) (136.48 KB - PDF)

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

Adopted Reference Number: EMA/553606/2019

English (EN) (1.5 MB - PDF)

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Dengvaxia : EPAR - Public assessment report

Adopted Reference Number: EMA/791273/2018

English (EN) (4.35 MB - PDF)

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CHMP summary of positive opinion for Dengvaxia

Adopted Reference Number: EMA/CHMP/666423/2018

English (EN) (121.1 KB - PDF)

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