This is a summary of the European public assessment report (EPAR) for Prevenar 13. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Prevenar 13.
Therapeutic Indication
### Therapeutic indication Active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to 17 years of age. Active immunisation for the prevention of invasive disease caused by Streptococcus pneumoniae in adults ?18 years of age and the elderly. See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes. The use of Prevenar 13 should be determined on the basis of official recommendations taking into consideration the risk of invasive disease in different age groups, underlying comorbidities as well as the variability of serotype epidemiology in different geographical areas.
Therapeutic Area (MeSH)
ATC Code
J07AL02
ATC Item
pneumococcus, purified polysaccharides antigen conjugated
Pharmacotherapeutic Group
Vaccines
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| Pneumococcal polysaccharide serotype 1 | N/A | pneumococcal polysaccharide serotype 1 |
| Pneumococcal polysaccharide serotype 3 | N/A | pneumococcal polysaccharide serotype 3 |
| 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 6A | N/A | Streptococcus pneumoniae type 6a capsular polysaccharide antigen |
| 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 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 19A | N/A | pneumococcal polysaccharide serotype 19 a |
| Pneumococcal polysaccharide serotype 19F | N/A | Streptococcus pneumoniae type 19f capsular polysaccharide antigen |
| Pneumococcal polysaccharide serotype 23F | N/A | Streptococcus pneumoniae type 23f capsular polysaccharide antigen |
EMA Name
Prevenar 13
Medicine Name
Prevenar 13
Aliases
N/ANo risk management plan link.
