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Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals

Active Substance: split influenza virus, inactivated, containing antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)
Common Name: prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
ATC Code: J07BB02
Marketing Authorisation Holder: GlaxoSmithKline Biologicals S.A.
Active Substance: split influenza virus, inactivated, containing antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)
Status: Withdrawn
Authorisation Date: 2008-09-26
Therapeutic Area: Influenza, Human Immunization Disease Outbreaks
Pharmacotherapeutic Group: Vaccines

Therapeutic 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.

The marketing authorisation for Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals has been withdrawn at the request of the marketing-authorisation holder.

Source: European Medicines Agency

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