🇪🇺 Vaxneuvance vaccine in European Union

EMA authorised Vaxneuvance vaccine on 13 December 2021

Marketing authorisation

EMA — authorised 13 December 2021

  • Application: EMEA/H/C/005477
  • Marketing authorisation holder: Merck Sharp & Dohme B.V.
  • Local brand name: Vaxneuvance
  • Indication: Vaxneuvance is indicated for active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years of age. Vaxneuvance is indicated for active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older. See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes. The use of Vaxneuvance should be in accordance with official recommendations.
  • Status: approved

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Other Immunology approved in European Union

Frequently asked questions

Is Vaxneuvance vaccine approved in European Union?

Yes. EMA authorised it on 13 December 2021.

Who is the marketing authorisation holder for Vaxneuvance vaccine in European Union?

Merck Sharp & Dohme B.V. holds the EU marketing authorisation.