Synflorix™ receives positive opinion from the CHMP in Europe for additional pneumonia indication

GlaxoSmithKline plc (GSK) today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending an additional indication for Synflorix™, a paediatric pneumococcal conjugate vaccine, for immunisation against pneumonia caused by Streptococcus pneumoniae in infants and children from six weeks up to five years of age.[i]

The application was submitted as a variation to the Marketing Authorisation Application to the European Medicines Agency.

"Pneumonia continues to be one of the leading global killers of children under five years of age, with an estimated three million cases of pneumonia in Europe alone", said Thomas Breuer, Senior Vice President and Lead Physician of GSK Vaccines. "Vaccination is recognised by The World Health Organization to be the only public health measure likely to have any significant impact on the incidence of pneumococcal pneumonia. Today's CHMP positive opinion takes us a step closer to offering greater protection to children against this disease. We look forward to the final decision of the European Commission and hope to make Synflorix™ available to more children in Europe."

A CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission, but does not always result in marketing authorisation. A final decision by the European Commission is anticipated during the fourth quarter of 2013.

Notes to Editors:

About Synflorix™
Synflorix™ is currently approved in the EU and 90 other countries for active immunisation against invasive disease and acute otitis media caused byStreptococcus pneumoniae in infants and children from six weeks up to five years of age. Around 40 countries and regions have chosen Synflorix™ in their universal mass vaccination programmes and 67 countries already have the indication for pneumonia approved. Synflorix™ is not approved for use in the U.S.

Important Safety Information

The most common adverse reactions observed after primary vaccination withSynflorix™ in infants were redness at the injection site and irritability. For further important safety information about the currently licensed indications for Synflorix™, please visit the Electronic Medicines Compendium to view the Synflorix™ EU Patient Information Leaflet.

GSK – 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

GSK enquiries:




UK Media enquiries:

David Mawdsley

+44 (0) 20 8047 5502



Simon Steel

+44 (0) 20 8047 5502



David Daley

+44 (0) 20 8047 5502



Catherine Hartley

+44 (0) 20 8047 5502






US Media enquiries:

Stephen Rea

+1 215 751 4394



Melinda Stubbee

+1 919 483 2510

(North Carolina)


Mary Anne Rhyne

+1 919 483 0492

(North Carolina)


Sarah Alspach

+1 202 715 1048

(Washington, DC)


Jennifer Armstrong

+1 215 751 5664






Analyst/Investor enquiries:

Sally Jackson

+44 20 8047 5543



Kirsty Collins (SRI & CG)

+44 20 8047 5534



Tom Curry

+ 1 215 751 5419



Gary Davies

+ 44 (0) 20 8047 5503



James Dodwell

+ 44 (0) 20 8047 2406



Jeff McLaughlin

+ 1 215 751 7002



Ziba Shamsi

+ 44 (0) 20 8047 3289



Lucy Singah

+44 (0) 20 8047 2248



Cautionary statement regarding forward-looking statements
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 Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2012.


Virtual Clinical Trials Summit

Virtual Clinical Trials Summit: The Premier Educational Event Focused on Decentralized Clinical Trials

In this virtual environment, we will look at current and future trends for ongoing virtual trials, diving into the many ways companies can improve patient engagement and trial behavior to enhance retention with a focus on emerging technology and harmonized data access across the clinical trial system.