Prevenar (pneumococcal saccharide conjugated vaccine, adsorbed)
- Region
- 🇪🇺 EU
- Active substance
- pneumococcal saccharide conjugated vaccine, adsorbed
- Company
- Pfizer Limited
- Status
- Withdrawn
- Therapeutic area
- Pneumococcal Infections; Immunization
- EU approval
- Fri 02 Feb 2001
- Application
- EMEA/H/C/000323
- ATC
- J07AL02
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.