Synflorix (pneumococcal polysaccharide conjugate vaccine (adsorbed))
- Region
- 🇪🇺 EU
- Active substance
- pneumococcal polysaccharide conjugate vaccine (adsorbed)
- Company
- GlaxoSmithKline Biologicals S.A.
- Status
- Authorised
- Therapeutic area
- Pneumococcal Infections; Immunization
- EU approval
- Sun 29 Mar 2009
- Application
- EMEA/H/C/000973
- ATC
- J07AL52
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Vaxneuvance Authorised · Merck Sharp & Dohme B.V.
Follow Synflorix
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.