CHMP recommend additional indication for Synflorix (GSK)

The EMA's CHMP has issued a positive opinion recommending an additional indication for Synflorix (paediatric pneumococcal conjugate vaccine), from Glaxo Smith Kline, for immunisation against Pneumonia caused by Streptococcus pneumoniae in infants and children from six weeks up to five years of age. Application was submitted as a variation to the Marketing Authorization Application to the European Medicines Agency.

Synflorix is currently approved in the E.U. and 90 other countries for active immunization 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.