Comirnaty (COVID-19 mRNA vaccine)
- Region
- 🇪🇺 EU
- Active substance
- COVID-19 mRNA vaccine
- Company
- BioNTech Manufacturing GmbH
- Status
- Authorised
- Therapeutic area
- COVID-19 virus infection
- CHMP opinion
- Mon 21 Dec 2020
- EU approval
- Mon 21 Dec 2020
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005735
- ATC
- J07BN01
- Official record
- www.ema.europa.eu
Indication
Comirnaty LP.8.1 dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations. Comirnaty XFG dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months 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
- 🇪🇺 Spikevax (previously COVID-19 Vaccine Moderna) Authorised · Moderna Biotech Spain, S.L.
- 🇪🇺 mNexspike Authorised · Moderna Biotech Spain, S.L.
- 🇪🇺 mCombriax Authorised · Moderna Biotech Spain, S.L.
- 🇪🇺 CureVac’s COVID-19 vaccine (CVnCoV) Withdrawn from rolling review · CureVac AG
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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.