🇪🇺 H5N1 vaccine (Arepanrix) in European Union

EMA authorised H5N1 vaccine (Arepanrix) on 23 March 2010

Marketing authorisation

EMA — authorised 23 March 2010

  • Application: EMEA/H/C/001201
  • Marketing authorisation holder: GlaxoSmithKline Biologicals S.A.
  • Local brand name: Arepanrix
  • Indication: Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidance
  • Pathway: conditional
  • Status: withdrawn

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Other Immunology approved in European Union

Frequently asked questions

Is H5N1 vaccine (Arepanrix) approved in European Union?

Yes. EMA authorised it on 23 March 2010.

Who is the marketing authorisation holder for H5N1 vaccine (Arepanrix) in European Union?

GlaxoSmithKline Biologicals S.A. holds the EU marketing authorisation.