Foclivia (pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted))
Exceptional circumstances
- Region
- 🇪🇺 EU
- Active substance
- pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
- Company
- Seqirus S.r.l.
- Status
- Authorised
- Therapeutic area
- Influenza, Human; Immunization; Disease Outbreaks
- CHMP opinion
- Thu 23 Jul 2009
- EU approval
- Sun 18 Oct 2009
- Designations
- Exceptional circumstances
- Application
- EMEA/H/C/001208
- ATC
- J07BB02
- Official record
- www.ema.europa.eu
Indication
Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidance.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Incellipan Authorised · Seqirus Netherlands B.V.
- 🇪🇺 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.