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Nuvaxovid (COVID-19 Vaccine (recombinant, adjuvanted))

Additional monitoring
Region
🇪🇺 EU
Active substance
COVID-19 Vaccine (recombinant, adjuvanted)
Company
Sanofi Winthrop Industrie
Status
Authorised
Therapeutic area
COVID-19 virus infection
CHMP opinion
Mon 20 Dec 2021
EU approval
Mon 20 Dec 2021
Designations
Additional monitoring
Application
EMEA/H/C/005808
ATC
J07BN04
Official record
www.ema.europa.eu

Indication

Nuvaxovid is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.The use of this vaccine should be in accordance with official recommendations. Nuvaxovid XBB.1.5 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.The use of this vaccine should be in accordance with official recommendations. Nuvaxovid XFG is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. The use of this vaccine should be in accordance with official recommendations.

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

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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.