Regulatory Update: GSK announces submission for a new indication for Synflorix™ in Europe
GlaxoSmithKline plc (GSK) announced today that it has submitted a regulatory application in the European Union (EU) seeking approval of an additional indication for Synflorix, a paediatric pneumococcal vaccine, for the active immunisation against pneumonia caused by Streptococcus pneumoniae in infants and children from 6 weeks up to 5 years of age.
Issued: London, UK
GlaxoSmithKline plc (GSK) announced today that it has submitted a regulatory application in the European Union (EU) seeking approval of an additional indication for Synflorix™, a paediatric pneumococcal vaccine, for the active immunisation against pneumonia caused by Streptococcus pneumoniae in infants and children from 6 weeks up to 5 years of age.
The application was submitted as a variation to the Marketing Authorisation Application to the European Medicines Agency.
About Synflorix™
Synflorix™ is currently approved in the EU and 90 other countries for active immunisation against invasive disease and acute otitis media caused by Streptococcus pneumoniae in infants and children from six weeks up to five years of age. Of these 90 countries, 67 already have the indication for pneumonia approved. Synflorix™ is not approved for use in the US.
Important Safety Information
The most common adverse reactions observed after primary vaccination with Synflorix™ in infants were redness at the injection site and irritability. For more important safety information about the currently licensed indications for Synflorix, please visit the Synflorix page on eMC to view the Synflorix EU Patient Information Leaflet.
GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.
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Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk factors' in the 'Financial review & risk' section in the company's Annual Report 2011 included as exhibit 15.2 to the company's Annual Report on Form 20-F for 2011.
