🇪🇺 Xofluza in European Union

EMA authorised Xofluza on 7 January 2021

Marketing authorisation

EMA — authorised 7 January 2021

  • Application: EMEA/H/C/004974
  • Marketing authorisation holder: Roche Registration GmbH
  • Local brand name: Xofluza
  • Indication: Treatment of influenza Xofluza is indicated for the treatment of uncomplicated influenza in patients aged 1 year and above. Post exposure prophylaxis of influenza Xofluza is indicated for post-exposure prophylaxis of influenza in individuals aged 1 year and above. Xofluza should be used in accordance with official recommendations.
  • Status: approved

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Xofluza in other countries

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

Other Infectious Disease approved in European Union

Frequently asked questions

Is Xofluza approved in European Union?

Yes. EMA authorised it on 7 January 2021.

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

Roche Registration GmbH holds the EU marketing authorisation.