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.
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.
Therapeutic Area (MeSH)
ATC Code
J07AL52
ATC Item
pneumococcus purified polysaccharides antigen and haemophilus influenzae, conjugated
Pharmacotherapeutic Group
Vaccines
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| Pneumococcal polysaccharide serotype 23F | N/A | Streptococcus pneumoniae type 23f capsular polysaccharide antigen |
| Pneumococcal polysaccharide serotype 4 | N/A | Streptococcus pneumoniae type 4 capsular polysaccharide antigen |
| Pneumococcal polysaccharide serotype 5 | N/A | pneumococcal polysaccharide serotype 5 |
| Pneumococcal polysaccharide serotype 6B | N/A | Streptococcus pneumoniae type 6b capsular polysaccharide antigen |
| Pneumococcal polysaccharide serotype 7F | N/A | pneumococcal polysaccharide serotype 7 f |
| Pneumococcal polysaccharide serotype 9V | N/A | Streptococcus pneumoniae type 9v capsular polysaccharide antigen |
| Pneumococcal polysaccharide serotype 1 | N/A | pneumococcal polysaccharide serotype 1 |
| Pneumococcal polysaccharide serotype 14 | N/A | Streptococcus pneumoniae type 14 capsular polysaccharide antigen |
| Pneumococcal polysaccharide serotype 18C | N/A | Streptococcus pneumoniae type 18c capsular polysaccharide antigen |
| Pneumococcal polysaccharide serotype 19F | N/A | Streptococcus pneumoniae type 19f capsular polysaccharide antigen |
EMA Name
Synflorix
Medicine Name
Synflorix
Aliases
N/A