Dukoral

RSS

cholera vaccine (inactivated, oral)

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

Overview

Dukoral is a vaccine that is given by mouth to protect people against cholera, a serious disease that causes severe diarrhoea. It is used in people aged from 2 years who will be visiting areas with high risk of cholera. Cholera is caused by the bacterium Vibrio cholerae (V. cholerae), which is caught from contaminated food or water.

Dukoral should be used according to official recommendations, taking into account where cholera occurs and the risk of catching the disease.

The vaccine contains 4 different inactivated strains (types) of V. cholerae serotype O1, and part of a toxin from one of these strains as active substances.

This EPAR was last updated on 06/04/2022

Authorisation details

Product details
Name
Dukoral
Agency product number
EMEA/H/C/000476
Active substance
  • recombinant cholera toxin B subunit
  • vibrio cholerae 01
International non-proprietary name (INN) or common name
cholera vaccine (inactivated, oral)
Therapeutic area (MeSH)
  • Cholera
  • Immunization
Anatomical therapeutic chemical (ATC) code
J07AE01
Publication details
Marketing-authorisation holder
Valneva Sweden AB
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
28/04/2004
Contact address
S-105 21 Stockholm
Sweden

Product information

07/01/2021 Dukoral - EMEA/H/C/000476 - II/0062/G

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

Dukoral is indicated for active immunisation against disease caused by Vibrio cholerae serogroup O1 in adults and children from 2 years of age who will be visiting endemic/epidemic areas.

The use of Dukoral should be determined on the basis of official recommendations taking into consideration the variability of epidemiology and the risk of contracting disease in different geographical areas and travelling conditions.

Dukoral should not replace standard protective measures. In the event of diarrhoea measures of rehydration should be instituted.

Assessment history

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