Prepandrix (prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted))

Accelerated assessment

Region: 🇪🇺 EU
Active substance: prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Company: GlaxoSmithKline Biologicals S.A.
Status: Withdrawn
Therapeutic area: Influenza, Human; Immunization; Disease Outbreaks
EU approval: Wed 14 May 2008
Designations: Accelerated assessment
Application: EMEA/H/C/000822
ATC: J07BB02
Official record: www.ema.europa.eu

Indication

Active immunisation against H5N1 subtype of influenza-A virus. This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of vaccine prepared with H5N1 subtype strains. Prepandrix should be used in accordance with official guidance.

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

🇪🇺 Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals Withdrawn · GlaxoSmithKline Biologicals S.A.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.