Dengue Tetravalent Vaccine (Live, Attenuated) Takeda: Opinion on medicine for use outside EU
dengue tetravalent vaccine (live, attenuated)
Table of contents
Overview
Dengue Tetravalent Vaccine (Live, Attenuated) Takeda 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 overview is for the vaccine intended for use outside the EU. An identical vaccine, Qdenga, is authorised in the European Union.
Opinion details
Product details | |
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Name of medicinal product |
Dengue Tetravalent Vaccine (Live, Attenuated) Takeda
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Agency opinion number |
EMEA/H/W/005362
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Opinion status |
Positive opinion
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Active substance |
|
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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Publication details | |
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Opinion holder |
Byk-Gulden-Strasse 2 |
Date of opinion |
13/10/2022
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Product information
Dengue Tetravalent Vaccine (Live, Attenuated) Takeda
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturer responsible for batch release
- Annex IIB - Recommendations to the opinion holder - conditions of use
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Pharmacotherapeutic group
Vaccines
Therapeutic indication
Dengue Tetravalent Vaccine (Live, Attenuated) Takeda is indicated for the prevention of dengue disease in individuals from 4 years of age.
The use of Dengue Tetravalent Vaccine (Live, Attenuated) Takeda should be in accordance with official recommendations.
Assessment history
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List item
Dengue Tetravalent Vaccine (Live, Attenuated) Takeda : Public assessment report (PDF/11.36 MB)
Adopted
First published: 14/12/2022
EMA/862556/2022 -
List item
Dengue Tetravalent Vaccine (Live, Attenuated) Takeda : All authorised presentations (PDF/95.27 KB)
First published: 14/12/2022 -
List item
CHMP summary of positive opinion for Dengue Tetravalent Vaccine (Live, Attenuated) Takeda (PDF/99.47 KB)
Adopted
First published: 14/10/2022
EMA/CHMP/781055/2022