Qdenga

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dengue tetravalent vaccine (live, attenuated)

Authorised
This medicine is authorised for use in the European Union.

Overview

Qdenga is a vaccine that helps protect against dengue disease. The vaccine can be given to adults, adolescents and children from 4 years of age.

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.

This vaccine contains attenuated (weakened) versions of dengue virus serotypes (varieties) 1, 2, 3 and 4.

This EPAR was last updated on 12/04/2023

Authorisation details

Product details
Name
Qdenga
Agency product number
EMEA/H/C/005155
Active substance
  • Dengue virus, serotype 2, expressing Dengue virus, serotype 1, surface proteins, live, attenuated
  • Dengue virus, serotype 2, expressing Dengue virus, serotype 3, surface proteins, live, attenuated
  • Dengue virus, serotype 2, expressing Dengue virus, serotype 4, surface proteins, live, attenuated
  • Dengue virus, serotype 2, live, attenuated
International non-proprietary name (INN) or common name
dengue tetravalent vaccine (live, attenuated)
Therapeutic area (MeSH)
Dengue
Anatomical therapeutic chemical (ATC) code
J07BX04
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
Takeda GmbH
Date of issue of marketing authorisation valid throughout the European Union
05/12/2022
Contact address
Byk-Gulden-Strasse 2
D-78467 Konstanz
Germany

Product information

Qdenga - EMEA/H/C/005155 -

Other EU languages available icon 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:

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

Qdenga is indicated for the prevention of dengue disease in individuals from 4 years of age.

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

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