Dukoral
cholera vaccine (inactivated, oral)
Table of contents
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.
Authorisation details
Product details | |
---|---|
Name |
Dukoral
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Agency product number |
EMEA/H/C/000476
|
Active substance |
|
International non-proprietary name (INN) or common name |
cholera vaccine (inactivated, oral)
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
J07AE01
|
Publication details | |
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Marketing-authorisation holder |
Valneva Sweden AB
|
Revision |
13
|
Date of issue of marketing authorisation valid throughout the European Union |
28/04/2004
|
Contact address |
S-105 21 Stockholm
Sweden |
Product information
01/08/2019 Dukoral - EMEA/H/C/000476 - IB/0060/G
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
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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.