🇪🇺 Recombinant in European Union

EMA authorised Recombinant on 16 November 2020

Marketing authorisation

EMA — authorised 16 November 2020

  • Application: EMEA/H/C/005159
  • Marketing authorisation holder: Sanofi Winthrop Industrie
  • Local brand name: Supemtek Tetra (previously Supemtek)
  • Indication: Supemtek Tetra is indicated for active immunization for the prevention of influenza disease in adults and children from 9 years of age and older. Supemtek Tetra should be used in accordance with official recommendations.
  • Status: approved

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Recombinant 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 Recombinant approved in European Union?

Yes. EMA authorised it on 16 November 2020.

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

Sanofi Winthrop Industrie holds the EU marketing authorisation.