Basic Information
Synflorix
Regulatory Information
EMEA/H/C/000973
March 29, 2009
36
May 24, 2023
Company Information
Belgium
Rue de l'Institut, 89 B-1330 Rixensart
GlaxoSmithKline Biologicals SA
Active Substances Detail
Pneumococcal polysaccharide serotype 23FPneumococcal polysaccharide serotype 4Pneumococcal polysaccharide serotype 5Pneumococcal polysaccharide serotype 6BPneumococcal polysaccharide serotype 7FPneumococcal polysaccharide serotype 9VPneumococcal polysaccharide serotype 1Pneumococcal polysaccharide serotype 14Pneumococcal polysaccharide serotype 18CPneumococcal polysaccharide serotype 19F
Pneumococcal polysaccharide serotype 5
Pneumococcal polysaccharide serotype 7F
Pneumococcal polysaccharide serotype 1
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication 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. See sections 4.4 and 5.1 in product information for information on protection against specific pneumococcal serotypes. The use of Synflorix should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as the variability of serotype epidemiology in different geographical areas.
Overview Summary
This is a summary of the European public assessment report (EPAR) for Synflorix. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Synflorix. For practical information about using Synflorix, patients should read the package leaflet or contact their doctor or pharmacist.