Pumarix (pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted))
Exceptional circumstances
- Region
- 🇪🇺 EU
- Active substance
- pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
- Company
- GlaxoSmithKline Biologicals S.A.
- Status
- Withdrawn
- Therapeutic area
- Influenza, Human; Immunization; Disease Outbreaks
- EU approval
- Fri 04 Mar 2011
- Designations
- Exceptional circumstances
- Application
- EMEA/H/C/001212
- 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
- 🇪🇺 Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals) Authorised · GlaxoSmithKline Biologicals S.A.
- 🇪🇺 Prepandrix Withdrawn · GlaxoSmithKline Biologicals S.A.
- 🇪🇺 Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals Withdrawn · GlaxoSmithKline Biologicals S.A.
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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.