🇪🇺 BIMERVAX in European Union

EMA authorised BIMERVAX on 30 March 2023

Marketing authorisation

EMA — authorised 30 March 2023

  • Application: EMEA/H/C/006058
  • Marketing authorisation holder: Hipra Human Health S.L.
  • Local brand name: Bimervax
  • Indication: Bimervax is indicated as a booster for active immunisation to prevent COVID-19 in individuals 12 years of age and older who have previously received a mRNA COVID-19 vaccine (see sections 4.2 and 5.1). The use of this vaccine should be in accordance with official recommendations. Bimervax XBB.1.16 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. The use of this vaccine should be in accordance with official recommendations. Bimervax LP.8.1 is indicated for active immunisation to prevent COVID-19 caused by SARS CoV-2 in indivi
  • Status: approved

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Other Infectious Diseases approved in European Union

Frequently asked questions

Is BIMERVAX approved in European Union?

Yes. EMA authorised it on 30 March 2023.

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

Hipra Human Health S.L. holds the EU marketing authorisation.