🇪🇺 Nuvaxovid in European Union

EMA authorised Nuvaxovid on 20 December 2021

Marketing authorisation

EMA — authorised 20 December 2021

  • Application: EMEA/H/C/005808
  • Marketing authorisation holder: Sanofi Winthrop Industrie
  • Local brand name: Nuvaxovid
  • 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.
  • Status: approved

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Nuvaxovid in other countries

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

Other Other approved in European Union

Frequently asked questions

Is Nuvaxovid approved in European Union?

Yes. EMA authorised it on 20 December 2021.

Who is the marketing authorisation holder for Nuvaxovid in European Union?

Sanofi Winthrop Industrie holds the EU marketing authorisation.