LONDON--GlaxoSmithKline PLC (>> GlaxoSmithKline plc), a research-based pharmaceutical and healthcare company, said Monday it has submitted a regulatory application in the European Union, or E.U., seeking approval of an additional indication for Synflorix(>> TOYOTA MOTOR CORPORATION), a paediatric pneumococcal vaccine, for the active immunization 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.
-Synflorix isn't approved for use in the U.S.
-Shares at 0935 GMT up 7 pence, or 0.49%, at 1424 pence valuing the company at 70.3 million pounds
-Write to Ian Walker at firstname.lastname@example.org
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