Dengvaxia (dengue tetravalent vaccine (live, attenuated))
- Region
- 🇪🇺 EU
- Active substance
- dengue tetravalent vaccine (live, attenuated)
- Company
- Sanofi Winthrop Industrie
- Status
- Withdrawn
- Therapeutic area
- Dengue
- CHMP opinion
- Wed 17 Oct 2018
- EU approval
- Wed 12 Dec 2018
- Application
- EMEA/H/C/004171
- ATC
- J07BX
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Qdenga Authorised · Takeda Pharmaceuticals International AG Ireland Branch
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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.