Incellipan (pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures))
ConditionalAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- pandemic 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
- Conditional, Additional monitoring
- Application
- EMEA/H/C/006051
- ATC
- J07BB02
- Official record
- www.ema.europa.eu
Indication
Incellipan is indicated for active immunisation against influenza in an officially declared pandemic. Incellipan should be used in accordance with official recommendations.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Foclivia Authorised · Seqirus S.r.l.
- 🇪🇺 Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics Expired · Novartis Vaccines and Diagnostics 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.