🇪🇺 Oral cholera vaccine in European Union

EMA authorised Oral cholera vaccine on 28 April 2004

Marketing authorisation

EMA — authorised 28 April 2004

  • Application: EMEA/H/C/000476
  • Marketing authorisation holder: Valneva Sweden AB
  • Local brand name: Dukoral
  • 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.
  • Status: approved

Read official source →

Oral cholera vaccine in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Oral cholera vaccine approved in European Union?

Yes. EMA authorised it on 28 April 2004.

Who is the marketing authorisation holder for Oral cholera vaccine in European Union?

Valneva Sweden AB holds the EU marketing authorisation.