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Bimervax (COVID-19 Vaccine (recombinant, adjuvanted))

Additional monitoring
Region
🇪🇺 EU
Active substance
COVID-19 Vaccine (recombinant, adjuvanted)
Company
Hipra Human Health S.L.
Status
Authorised
Therapeutic area
COVID-19 virus infection
EU approval
Thu 30 Mar 2023
Designations
Additional monitoring
Application
EMEA/H/C/006058
ATC
J07BN
Official record
www.ema.europa.eu

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 individuals 12 years of age and older. The use of this vaccine should be in accordance with official recommendations.

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.