Dukoral

RSS

cholera vaccine (inactivated, oral)

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

Overview

This is a summary of the European public assessment report (EPAR) for Dukoral. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Dukoral.

This EPAR was last updated on 23/10/2018

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
12
Date of issue of marketing authorisation valid throughout the European Union
27/04/2004
Contact address
S-105 21 Stockholm
Sweden

Product information

18/07/2018 Dukoral - EMEA/H/C/000476 - II/0058

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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