On 21 November 2017, the European Commission withdrew the marketing authorisation for Prevenar (pneumococcal polysaccharide conjugate vaccine (7\-valent, adsorbed)) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Pfizer Limited, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. Prevenar was granted marketing authorisation in the EU on 2 February 2001 for immunisation against disease caused by Streptococcus pneumoniae. The marketing authorisation was initially valid for a 5\- year period. It was subsequently renewed for an additional 5\-year period in 2006 and then granted unlimited validity in 2011\. The European Public Assessment Report (EPAR) for Prevenar is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Therapeutic Indication
Active immunisation against disease caused by *Streptococcus pneumoniae* serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media) in infants and children from two months up to five years of age. The use of Prevenar should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as variability of serotype epidemiology in different geographical areas.
Therapeutic Area (MeSH)
ATC Code
J07AL02
ATC Item
N/A
Pharmacotherapeutic Group
Vaccines
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| pneumococcal oligosaccharide serotype 18C | N/A | pneumococcal oligosaccharide serotype 18C |
| Pneumococcal polysaccharide serotype 19F | N/A | Pneumococcal polysaccharide serotype 19F |
| Pneumococcal polysaccharide serotype 23F | N/A | Pneumococcal polysaccharide serotype 23F |
| Pneumococcal polysaccharide serotype 4 | N/A | Pneumococcal polysaccharide serotype 4 |
| Pneumococcal polysaccharide serotype 6B | N/A | Pneumococcal polysaccharide serotype 6B |
| Pneumococcal polysaccharide serotype 9V | N/A | Pneumococcal polysaccharide serotype 9V |
| Pneumococcal polysaccharide serotype 14 | N/A | Pneumococcal polysaccharide serotype 14 |
EMA Name
Prevenar
Medicine Name
Prevenar
Aliases
N/ANo risk management plan link.