Vaxchora

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Cholera vaccine (recombinant, live, oral)

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

Overview

Vaxchora is a vaccine to prevent cholera disease in adults and children aged from 6 years.

The vaccine contains a weakened form of the cholera bacterium Vibrio cholerae (serogroup O1).

This EPAR was last updated on 08/04/2020

Authorisation details

Product details
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 (recombinant, live, oral)
Therapeutic area (MeSH)
Cholera
Anatomical therapeutic chemical (ATC) code
J07AE02
Additional monitoringAdditional 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
Marketing-authorisation holder
Emergent Netherlands B.V.
Date of issue of marketing authorisation valid throughout the European Union
01/04/2020
Contact address

Strawinskylaan 411
1077XX Amsterdam
Netherlands

Product information

01/04/2020 Vaxchora - EMEA/H/C/003876 -

Contents

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Pharmacotherapeutic group

Vaccines

Therapeutic indication

Vaxchora is indicated for active immunisation against disease caused by Vibrio cholerae serogroup O1 in adults and children aged 6 years and older.

This vaccine should be used in accordance with official recommendations.

Assessment history

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