Basic Information
Dengvaxia
Regulatory Information
EMEA/H/C/004171
December 12, 2018
October 17, 2018
7
January 15, 2025
Company Information
France
82 Avenue Raspail 94250 Gentilly
SANOFI WINTHROP INDUSTRIE
Active Substances Detail
chimeric yellow fever dengue virus serotype 1 (live, attenuated)chimeric yellow fever dengue virus serotype 2 (live, attenuated)chimeric yellow fever dengue virus serotype 3 (live, attenuated)chimeric yellow fever dengue virus serotype 4 (live, attenuated)
chimeric yellow fever dengue virus serotype 1 (live, attenuated)
chimeric yellow fever dengue virus serotype 2 (live, attenuated)
chimeric yellow fever dengue virus serotype 3 (live, attenuated)
chimeric yellow fever dengue virus serotype 4 (live, attenuated)
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Dengvaxia is indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 6 to 45 years of age with test-confirmed previous dengue infection (see sections 4.2, 4.4 and 4.8). The use of Dengvaxia should be in accordance with official recommendations.
Overview Summary
Dengvaxia is a vaccine used to help protect against dengue disease in people aged 6 to 45 years who have had a previous dengue virus infection. Dengue disease is a mosquito-borne tropical disease caused by the dengue virus, leading to mild, flu-like symptoms in most people. However, a small number of patients develop severe disease, with potentially fatal bleeding and organ damage. The risk of severe disease is higher in people who have been infected a second time. There are several varieties (called serotypes) of dengue virus and Dengvaxia protects against serotypes 1, 2, 3 and 4. Dengvaxia contains attenuated (weakened) yellow fever viruses that have been modified so that they contain proteins from dengue virus.