The additional indication is for the active immunisation against pneumonia caused by Streptococcus pneumoniae in infants and children from six weeks up to five years of age.
The company has submitted the application as a variation to the marketing authorisation application to the European Medicines Agency.
Synflorix is at present 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.
In 67 countries of the 90, Synflorix is approved for pneumonia while it is not approved for use in the US.