Vaxchora
cholera vaccine, oral, live
Table of contents
Overview
Vaxchora is a vaccine to prevent cholera disease in adults and children aged from 2 years. Cholera is a disease that is caught from contaminated food or drink and causes severe diarrhoea.
The vaccine contains a weakened form of the cholera bacterium Vibrio cholerae (serogroup O1).
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Vaxchora : EPAR - Medicine overview (PDF/133.16 KB)
First published: 08/04/2020
Last updated: 07/04/2021
EMA/69968/2021 -
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Vaxchora : EPAR - Risk-management-plan summary (PDF/120.56 KB)
First published: 08/04/2020
Last updated: 31/05/2022
Authorisation details
Product details | |
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Name |
Vaxchora
|
Agency product number |
EMEA/H/C/003876
|
Active substance |
vibrio cholerae, strain cvd 103-hgr, live
|
International non-proprietary name (INN) or common name |
cholera vaccine, oral, live
|
Therapeutic area (MeSH) |
Cholera
|
Anatomical therapeutic chemical (ATC) code |
J07AE02
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Publication details | |
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Marketing-authorisation holder |
Bavarian Nordic A/S
|
Revision |
7
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Date of issue of marketing authorisation valid throughout the European Union |
01/04/2020
|
Contact address |
Bavarian Nordic A/S |
Product information
22/09/2022 Vaxchora - EMEA/H/C/003876 - T/0021
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
Vaxchora is indicated for active immunisation against disease caused by Vibrio cholerae serogroup O1 in adults and children aged 2 years and older.
This vaccine should be used in accordance with official recommendations.