On the 26 September 2008 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Prepandemic influenza vaccine (H5N1) GlaxoSmithKline Biologicals, prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) A/VietNam/1194/2004 NIBRG-14, which had been approved as for prophylaxis of influenza in an officially declared pandemic situation.
The marketing authorisation holder (MAH) responsible for Prepandemic influenza vaccine (H5N1) GlaxoSmithKline Biologicals was GlaxoSmithKline Biologicals S.A. The European Commission was notified by a letter dated 12 August 2011 of the MAH’s decision to voluntarily withdraw the marketing authorisation as of the Commission Decision date for Prepandemic influenza vaccine (H5N1) GlaxoSmithKline Biologicals for commercial reasons. Prepandemic influenza vaccine (H5N1) GlaxoSmithKline Biologicals was not marketed in any country of the European Union.
On 3 October 2011 the European Commission issued a decision to withdraw the marketing authorisation for Prepandemic influenza vaccine (H5N1) GlaxoSmithKline Biologicals.
Pursuant to this decision the European Public Assessment Report for Prepandemic influenza vaccine (H5N1) GlaxoSmithKline Biologicals is updated to reflect that the marketing authorisation is no longer valid.
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
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.