Dengue Tetravalent Vaccine (Live, Attenuated) Takeda: Opinion on medicine for use outside EU

dengue tetravalent vaccine (live, attenuated)

Opinion on medicine for use outside the European Union
Positive opinion

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
Name of medicinal product
Dengue Tetravalent Vaccine (Live, Attenuated) Takeda
Agency opinion number
EMEA/H/W/005362
Opinion status
Positive opinion
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
Publication details
Opinion holder

Byk-Gulden-Strasse 2
D-78467 Konstanz
Germany

Date of opinion
13/10/2022

Product information

Dengue Tetravalent Vaccine (Live, Attenuated) Takeda

Contents

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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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