Pandemic Influenza Vaccine H5N1 Baxter AG (pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture))
Exceptional circumstances
- Region
- 🇪🇺 EU
- Active substance
- pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture)
- Company
- Resilience Biomanufacturing Ireland Limited
- Status
- Withdrawn
- Therapeutic area
- Influenza, Human; Immunization; Disease Outbreaks
- CHMP opinion
- Sun 23 Aug 2009
- EU approval
- Fri 16 Oct 2009
- Designations
- Exceptional circumstances
- Application
- EMEA/H/C/001200
- ATC
- J07BB01
- 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
- 🇪🇺 Vepacel Withdrawn · Ology Bioservices Ireland LTD
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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.