Supemtek (trivalent influenza vaccine (recombinant, prepared in cell culture))
- Region
- 🇪🇺 EU
- Active substance
- trivalent influenza vaccine (recombinant, prepared in cell culture)
- Company
- Sanofi Winthrop Industrie
- Status
- Authorised
- Therapeutic area
- Influenza, Human
- CHMP opinion
- Thu 29 Jan 2026
- EU approval
- Mon 30 Mar 2026
- Application
- EMEA/H/C/006674
- ATC
- J07BB02
- Official record
- www.ema.europa.eu
Indication
Supemtek is indicated for active immunisation for the prevention of influenza disease in adults and children from 9 years of age and older. Supemtek should be used in accordance with official recommendations.
Regulatory milestones
Mon 30 Mar 2026🇪🇺 EU approval (EC decision)
Supemtek (trivalent influenza vaccine (recombinant, prepared in cell culture)) approved in the EU
Marketing authorisation to Sanofi Winthrop Industrie · source
Thu 29 Jan 2026🇪🇺 CHMP positive opinion
Supemtek (trivalent influenza vaccine (recombinant, prepared in cell culture)): CHMP positive opinion
Follow Supemtek
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.