Celldemic (zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures))
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures)
- Company
- Seqirus Netherlands B.V.
- Status
- Authorised
- Therapeutic area
- Influenza, Human
- CHMP opinion
- Thu 22 Feb 2024
- EU approval
- Fri 19 Apr 2024
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006052
- ATC
- J07BB02
- Official record
- www.ema.europa.eu
Indication
Celldemic is indicated for active immunisation against H5N1 subtype of Influenza A virus in adults and infants from 6 months of age and above. Celldemic should be used in accordance with official recommendations.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Aflunov Authorised · Seqirus S.r.l.
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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.