Dukoral (cholera vaccine (inactivated, oral))
- Region
- 🇪🇺 EU
- Active substance
- cholera vaccine (inactivated, oral)
- Company
- Valneva Sweden AB
- Status
- Authorised
- Therapeutic area
- Cholera; Immunization
- EU approval
- Wed 28 Apr 2004
- Application
- EMEA/H/C/000476
- ATC
- J07AE01
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.