27 April 2012, London UK - GlaxoSmithKline plc (GSK) announced today that the European Commission has granted marketing authorisation for Nimenrix (Meningococcal group A, C, W-135 and Y conjugate vaccine) for active immunisation against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W-135 and Y.
Thomas Breuer, Senior Vice-President, Head of Global Vaccine Development at GSK, commented: “GSK is pleased to have received approval in Europe for Nimenrix and looks forward to making this vaccine available to help protect individuals against what can be a life threatening disease.”
Nimenrix is the first quadrivalent conjugate vaccine to be approved in Europe for active immunisation of individuals from 12 months of age against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W -135 and Y. Nimenrix is provided as one dose and is generally well tolerated.
Detailed information on the use of Nimenrix and its safety profile are described in the Summary of Product Characteristics, which will be published on the EMA website, together with the European Public Assessment Report (EPAR, http://www.ema.europa.eu) and in the Community Register of Medicinal Products on the European Commission’s website (http://ec.europa.eu/health/documents/community-register/html/index_en.htm).
About Neisseria meningitides
Neisseria meningitidis is a highly contagious disease with potentially disabling consequences such as deafness, epilepsy and other neurological disorders; in severe cases it can even be life-threatening. The highest risk of contracting the disease is in infants and toddlers in the first 4 years of their lives, with a second peak in adolescents. Certain groups such as travellers to areas with high endemic levels of meningococcal disease (e.g., African meningitis belt) or exposure to overcrowded situations, (e.g., Hajj pilgrimage) may be at increased risk of meningococcal disease(1).
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.
GlaxoSmithKline Biologicals - (GSK Biologicals), GlaxoSmithKline’s vaccines business, is one of the world’s leading vaccine companies and a leader in innovation. The company is active in vaccine research, development and production with over 30 vaccines approved for marketing and 20 more in development - both in the prophylactic and therapeutic fields. Headquartered in Belgium, GSK Biologicals has 14 manufacturing sites strategically positioned around the globe. In 2010, GSK Biologicals distributed 1.43 billion doses of vaccines to 179 countries in both the developed and the developing world.
Through its accomplished and dedicated workforce, GSK Biologicals applies its expertise to the discovery of innovative vaccines that contribute to the health and well-being of people of all generations around the world.
1. World Health Organisation, Meningococcal vaccines: Polysaccharide and polysaccharide conjugate vaccines. WHO position paper. Weekly Epidemiological Record. 2002;77331-39
GlaxoSmithKline 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.
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