mCombriax (influenza mRNA vaccine;COVID-19 mRNA vaccine)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- influenza mRNA vaccine;COVID-19 mRNA vaccine
- Company
- Moderna Biotech Spain, S.L.
- Status
- Authorised
- Therapeutic area
- Influenza, Human; COVID-19 virus infection
- CHMP opinion
- Thu 26 Feb 2026
- EU approval
- Mon 20 Apr 2026
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006472
- ATC
- J07B
- Official record
- www.ema.europa.eu
Indication
mCombriax is indicated for active immunisation for the prevention of influenza disease and COVID-19 caused by SARS-CoV-2 in individuals 50 years of age and older. The use of this vaccine should be in accordance with official recommendations.
Regulatory milestones
Mon 20 Apr 2026🇪🇺 EU approval (EC decision)
mCombriax (influenza mRNA vaccine;COVID-19 mRNA vaccine) approved in the EU
Marketing authorisation to Moderna Biotech Spain, S.L.; Additional monitoring · source
Thu 26 Feb 2026🇪🇺 CHMP positive opinion
mCombriax (influenza mRNA vaccine;COVID-19 mRNA vaccine): CHMP positive opinion
Moderna Biotech Spain, S.L.; Additional monitoring · source
Follow mCombriax
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.