🇪🇺 Licensed RSV Vaccine in European Union

EMA authorised Licensed RSV Vaccine on 6 June 2023

Marketing authorisation

EMA — authorised 6 June 2023

  • Application: EMEA/H/C/006054
  • Marketing authorisation holder: GlaxoSmithKline Biologicals S.A.
  • Local brand name: Arexvy
  • Indication: Arexvy is indicated for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in adults 18 years of age and older.  The use of this vaccine should be in accordance with official recommendations.
  • Status: approved

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Other Respiratory approved in European Union

Frequently asked questions

Is Licensed RSV Vaccine approved in European Union?

Yes. EMA authorised it on 6 June 2023.

Who is the marketing authorisation holder for Licensed RSV Vaccine in European Union?

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