UK and German approvals for FLUARIX TETRA (GSK) influenza vaccine

GSK announced the marketing authorisation of its quadrivalent (four-strain) influenza vaccine in Germany and the UK. Following a decentralised procedure, Germany�s Paul Ehrlich Institut (PEI) was the first national regulatory authority in Europe to grant marketing authorisation for this influenza vaccine, followed by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK. This is the first four-strain influenza vaccine to be approved in a European country for active immunisation of adults and children from three years of age for the prevention of influenza disease caused by the two influenza A virus subtypes and the two influenza B virus types contained in the vaccine. The new four-strain vaccine will be marketed as INFLUSPLIT TETRA in Germany and FLUARIX TETRA in the UK.

INFLUSPLIT TETRA/FLUARIX TETRA is expected to be available for use in Germany and the UK in time for the 2013/2014 flu season. This vaccine was approved by the FDA in December 2012 (as FLUARIX QUADRIVALENT). GSK has also submitted licence applications for this vaccine in Australia, Switzerland and Taiwan. Regulatory decisions for these countries are expected over the coming months.