GlaxoSmithKline receives European authorisation for Nimenrix™ (Meningococcal group A, C, W-135 and Y conjugate vaccine)

GlaxoSmithKline receives European authorisation for Nimenrix™ (Meningococcal group A, C, W-135 and Y conjugate vaccine)

Issued: Friday 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."

About Nimenrix

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.

GlaxoSmithKline Enquiries:

UK Media enquiries:

David Mawdsley

+44 (0) 20 8047 5502

(London)

Stephen Rea

+44 (0) 20 8047 5502

(London)

Sarah Spencer

+44 (0) 20 8047 5502

(London)

David Daley

+44 (0) 20 8047 5502

(London)

 

 

US Media enquiries:

Kevin Colgan

+1 919 483 2839

(North Carolina)

Melinda Stubbee

+1 919 483 2839

(North Carolina)

Sarah Alspach

+1 919 483 2839

(Washington, DC)

Jennifer Armstrong

+1 919 483 2839

(Philadelphia)

 

Analyst/Investor enquiries:

Sally Ferguson

+44 (0) 20 8047 5543

(London)

Tom Curry

+ 1 215 751 5419

(Philadelphia)

Gary Davies

+ 44 (0) 20 8047 5503

(London)

Jeff McLaughlin

+ 1 215 751 7002

(Philadelphia)

Ziba Shamsi

+ 44 (0) 20 8047 3289

(London)

Reference

1.     World Health Organisation, Meningococcal vaccines: Polysaccharide and polysaccharide conjugate vaccines. WHO position paper. Weekly Epidemiological Record. 2002;77331-39

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