GlaxoSmithKline (GSK) has received the marketing authorization from Germany's Paul Ehrlich Institut (PEI) and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK for its quadrivalent (four-strain) influenza vaccine.
The new four-strain vaccine will be marketed as Influsplit Tetra in Germany and Fluarix Tetra 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, according to the company.
Influsplit Tetra/Fluarix Tetra has been developed to provide broader influenza strain coverage against two influenza A strains and two influenza B strains and is anticipated to be available for use in Germany and the UK for 2013/2014 flu season.
In December 2012, the vaccine was approved by the US Food and Drug Administration (FDA) as Fluarix Quadrivalent.
GSK has also submitted license applications for the influenza vaccine in Australia, Switzerland and Taiwan.
Regulatory approvals for these countries are expected over the coming months.
