Qdenga
dengue tetravalent vaccine (live, attenuated)
Table of contents
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.
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Qdenga : EPAR - Medicine Overview (PDF/105.37 KB)
First published: 16/12/2022
EMA/861969/2022 -
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Qdenga : EPAR - Risk Management Plan (PDF/630.37 KB)
First published: 16/12/2022
Authorisation details
Product details | |
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Name |
Qdenga
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Agency product number |
EMEA/H/C/005155
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Active substance |
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International non-proprietary name (INN) or common name |
dengue tetravalent vaccine (live, attenuated)
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Therapeutic area (MeSH) |
Dengue
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Anatomical therapeutic chemical (ATC) code |
J07BX04
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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. |
Publication details | |
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Marketing-authorisation holder |
Takeda GmbH
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Date of issue of marketing authorisation valid throughout the European Union |
05/12/2022
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Contact address |
Byk-Gulden-Strasse 2
D-78467 Konstanz Germany |
Product information
Qdenga - EMEA/H/C/005155 -
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).
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.