Pandemrix (influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted))

Region: 🇪🇺 EU
Active substance: influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
Company: GlaxoSmithKline Biologicals S.A.
Status: Expired
Therapeutic area: Influenza, Human; Immunization; Disease Outbreaks
EU approval: Tue 20 May 2008
Application: EMEA/H/C/000832
ATC: J07BB02
Official record: www.ema.europa.eu

Indication

Prophylaxis of influenza caused by A (H1N1)v 2009 virus. Pandemrix should only be used if the recommended annual seasonal trivalent / quadrivalent influenza vaccines are not available and if immunisation against (H1N1)v is considered necessary (see sections 4.4 and 4.8). Pandemrix should be used in accordance with Official Guidance.

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

🇪🇺 Arepanrix Withdrawn · GlaxoSmithKline Biologicals S.A.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.