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Regulatory Update: GSK Announces Submission for A New Indication for Synflorix in Europe

Issued: Monday 17 September 2012, 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 Synflorix - Vaccines - Our products - GlaxoSmithKline 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

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 2933
(North Carolina)


Melinda Stubbee
+1 919 483 2510
(North Carolina)


Sarah Alspach
+1 202 715 1048
(Washington, DC)


Jennifer Armstrong
+1 215 751 5664
(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)


James Dodwell
+ 44 (0) 20 8047 2406
(London)


Jeff McLaughlin
+ 1 215 751 7002
(Philadelphia)


Ziba Shamsi
+ 44 (0) 20 8047 3289

 

Posted: September 2012


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