Regulatory Update: GSK files Rotarix for prevention of rotavirus in Japan
GlaxoSmithKline (GSK) announced today that it has filed its vaccine for the prevention of rotavirus gastroenteritis (approved as Rotarix ® in a number of countries outside of Japan). The candidate vaccine, which is given orally, is the first to be filed for approval for the prevention of rotavirus gastroenteritis in infants in Japan. Rotavirus infection is the leading cause of severe acute gastroenteritis in infants.
GlaxoSmithKline (GSK) announced today that it has filed its vaccine for the prevention of rotavirus gastroenteritis (approved as Rotarix ® in a number of countries outside of Japan). The candidate vaccine, which is given orally, is the first to be filed for approval for the prevention of rotavirus gastroenteritis in infants in Japan. Rotavirus infection is the leading cause of severe acute gastroenteritis in infants.
For more information about Rotarix, please see the full prescribing information at www.gsk.com.
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 'Business Review' in the company' s Annual Report on Form 20-F for 2008.
