🇪🇺 RSV Vaccine in European Union

EMA authorised RSV Vaccine on 23 August 2023

Marketing authorisation

EMA — authorised 23 August 2023

  • Application: EMEA/H/C/006027
  • Marketing authorisation holder: Pfizer Europe MA EEIG
  • Local brand name: Abrysvo
  • Indication: Abrysvo is indicated for: Passive protection against lower respiratory tract disease caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age following maternal immunisation during pregnancy.  Active immunisation of individuals 18 years of age and older for the prevention of lower respiratory tract disease caused by RSV. The use of this vaccine should be in accordance with official recommendations.
  • Pathway: accelerated assessment
  • Status: approved

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Other Immunology / Infectious Disease approved in European Union

Frequently asked questions

Is RSV Vaccine approved in European Union?

Yes. EMA authorised it on 23 August 2023.

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

Pfizer Europe MA EEIG holds the EU marketing authorisation.