Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals (prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted))

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Status: Withdrawn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: Fri 26 Sep 2008
Application: EMEA/H/C/001015
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 from A/VietNam/1194/2004 NIBRG-14 (H5N1) (see section 5.1). Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg should be used in accordance with official guidance.

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

🇪🇺 Prepandrix Withdrawn · GlaxoSmithKline Biologicals S.A.

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