🇪🇺 FLUENZ in European Union

EMA authorised FLUENZ on 27 January 2011

Marketing authorisations

EMA — authorised 27 January 2011

  • Application: EMEA/H/C/001101
  • Marketing authorisation holder: MedImmune LLC
  • Local brand name: Fluenz
  • Indication: Prophylaxis of influenza in individuals 24 months to less than 18 years of age. The use of Fluenz should be based on official recommendations.
  • Status: withdrawn

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EMA — authorised 3 June 2024

  • Application: EMEA/H/C/006514
  • Marketing authorisation holder: AstraZeneca AB
  • Local brand name: Fluenz
  • Indication: Fluenz is indicated for active immunisation for the prevention of influenza disease in children and adolescents from 2 years to less than 18 years of age.Fluenz should be used in accordance with official recommendations.
  • Status: approved

On 3 June 2024, the European Medicines Agency (EMA) granted marketing authorisation for FLUENZ, an influenza vaccine, for active immunisation against influenza disease in children and adolescents from 2 years to less than 18 years of age. The vaccine should be used in accordance with official recommendations. AstraZeneca AB is the marketing authorisation holder.

Read official source →

FLUENZ in other countries

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

Frequently asked questions

Is FLUENZ approved in European Union?

Yes. EMA authorised it on 27 January 2011; EMA authorised it on 3 June 2024.

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

MedImmune LLC holds the EU marketing authorisation.