Ireland - English - HPRA (Health Products Regulatory Authority)

merck sharp & dohme ireland (human health) limited - pneumococcal vaccine - solution for injection in pre-filled syringe - 25 mcg/0.5 millilitre(s) - pneumococcal vaccines; pneumococcus, purified polysaccharides antigen

Ireland - English - HPRA (Health Products Regulatory Authority)

merck sharp & dohme ireland (human health) limited - pneumococcal vaccine - solution for injection - 25mcg/0.5 millilitre(s) - pneumococcal vaccines; pneumococcus, purified polysaccharides antigen

Singapore - English - HSA (Health Sciences Authority)

pfizer private limited - crm197 protein; pneumococcal polysaccharide serotype 1 (conjugate); pneumococcal polysaccharide serotype 14 (conjugate); pneumococcal polysaccharide serotype 18c (conjugate); pneumococcal polysaccharide serotype 19a (conjugate); pneumococcal polysaccharide serotype 19f (conjugate); pneumococcal polysaccharide serotype 23f (conjugate); pneumococcal polysaccharide serotype 3 (conjugate); pneumococcal polysaccharide serotype 4 (conjugate); pneumococcal polysaccharide serotype 5 (conjugate); pneumococcal polysaccharide serotype 6a (conjugate); pneumococcal polysaccharide serotype 6b (conjugate); pneumococcal polysaccharide serotype 7f (conjugate); pneumococcal polysaccharide serotype 9v (conjugate) - injection, suspension - 32mcg - crm197 protein 32mcg; pneumococcal polysaccharide serotype 1 (conjugate) 2.2mcg; pneumococcal polysaccharide serotype 14 (conjugate) 2.2mcg; pneumococcal polysaccharide serotype 18c (conjugate) 2.2mcg; pneumococcal polysaccharide serotype 19a (conjugate) 2.2mcg; pneumococcal polysaccharide serotype 19f (conjugate) 2.2mcg; pneumococcal polysaccharide serotype 23f (conjugate) 2.2mcg; pneumococcal polysaccharide serotype 3 (conjugate) 2.2mcg; pneumococcal polysaccharide serotype 4 (conjugate) 2.2mcg; pneumococcal polysaccharide serotype 5 (conjugate) 2.2mcg; pneumococcal polysaccharide serotype 6a (conjugate) 2.2mcg; pneumococcal polysaccharide serotype 6b (conjugate) 4.4mcg; pneumococcal polysaccharide serotype 7f (conjugate) 2.2mcg; pneumococcal polysaccharide serotype 9v (conjugate) 2.2mcg

Singapore - English - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - conjugate of streptococcus pneumoniae type 1 & haemophilus influenzae protein d; conjugate of streptococcus pneumoniae type 14 and haemophilus influenzae protein d; conjugate of streptococcus pneumoniae type 18c and tetanus toxoid; conjugate of streptococcus pneumoniae type 19f and diphtheria toxoid; conjugate of streptococcus pneumoniae type 23f and haemophilus influenzae protein d; conjugate of streptococcus pneumoniae type 4 and haemophilus influenzae protein d; conjugate of streptococcus pneumoniae type 5 and haemophilus influenzae protein d; conjugate of streptococcus pneumoniae type 6b and haemophilus influenzae protein d; conjugate of streptococcus pneumoniae type 7f and haemophilus influenzae protein d; conjugate of streptococcus pneumoniae type 9v and haemophilus influenzae protein d; diphtheria toxoid (dt) carrier protein; polysaccharide (ps); protein-d (pd) carrier protein (derived from non-typeable haemophilus influenzae); tetanus toxoid (tt) carrier protein - injection, suspension - 1 μg ps1; 1.11-1.67 μg pd/dose - conjugate of streptococcus pneumoniae type 1 & haemophilus influenzae protein d 1 μg ps1; 1.11-1.67 μg pd/dose; conjugate of streptococcus pneumoniae type 14 and haemophilus influenzae protein d 1 μg ps14; 1.00-1.82 μg pd/dose; conjugate of streptococcus pneumoniae type 18c and tetanus toxoid 3 μg ps18c; 5.45-10.00 μg tt/dose; conjugate of streptococcus pneumoniae type 19f and diphtheria toxoid 3 μg ps19f; 3.33-6.00 μg dt/dose; conjugate of streptococcus pneumoniae type 23f and haemophilus influenzae protein d 1 μg ps23f; 0.39-0.74 μg pd/dose; conjugate of streptococcus pneumoniae type 4 and haemophilus influenzae protein d 3 μg ps4; 3.33-6.67 μg pd/dose; conjugate of streptococcus pneumoniae type 5 and haemophilus influenzae protein d 1 μg ps5; 0.67-1.25 μg pd/dose; conjugate of streptococcus pneumoniae type 6b and haemophilus influenzae protein d 1 μg ps6b; 0.56-0.95 μg pd/dose; conjugate of streptococcus pneumoniae type 7f and haemophilus influenzae protein d 1 μg ps7f; 0.87-1.43 μg pd/dose; conjugate of streptococcus pneumoniae type 9v and haemophilus influenzae protein d 1 μg ps9v; 1.00-1.82 μg pd/dose; diphtheria toxoid (dt) carrier protein 3-6 μg dt/dose (total dt content); polysaccharide (ps) 16 μg/dose (total ps content); protein-d (pd) carrier protein (derived from non-typeable haemophilus influenzae) 9-16 μg pd/dose (total pd content); tetanus toxoid (tt) carrier protein 5-10 μg/dose (total tt content)

European Union - English - EMA (European Medicines Agency)

pfizer limited - pneumococcal oligosaccharide serotype 18c, pneumococcal polysaccharide serotype 19f, pneumococcal polysaccharide serotype 23f, pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 6b, pneumococcal polysaccharide serotype 9v, pneumococcal polysaccharide serotype 14 - pneumococcal infections; immunization - vaccines - 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.

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - pneumococcal polysaccharide serotype 1; pneumococcal polysaccharide serotype 14; pneumococcal polysaccharide serotype 18c; pneumococcal polysaccharide serotype 19 f; pneumococcal polysaccharide serotype 23f; pneumococcal polysaccharide serotype 4; pneumococcal polysaccharide serotype 5; pneumococcal polysaccharide serotype 6b; pneumococcal polysaccharide serotype 7f; pneumococcal polysaccharide serotype 9v - suspension for injection - pneumococcal polysaccharide serotype 19 f 3 mcg / 0.5 ml; pneumococcal polysaccharide serotype 1 1 mcg / 0.5 ml; pneumococcal polysaccharide serotype 4 3 mcg / 0.5 ml; pneumococcal polysaccharide serotype 5 1 mcg / 0.5 ml; pneumococcal polysaccharide serotype 6b 1 mcg / 0.5 ml; pneumococcal polysaccharide serotype 7f 1 mcg / 0.5 ml; pneumococcal polysaccharide serotype 9v 1 mcg / 0.5 ml; pneumococcal polysaccharide serotype 14 1 mcg / 0.5 ml; pneumococcal polysaccharide serotype 18c 3 mcg / 0.5 ml; pneumococcal polysaccharide serotype 23f 1 mcg / 0.5 ml - pneumococcus, purified polysaccharides antigen conjugated - pneumococcus, purified polysaccharides antigen conjugated - active immunisation against invasive disease, pneumonia and acute otitis media caused by streptococcus pneumoniae serotypes 1, 4, 5, 6b, 7f, 9v, 14, 18c, 19f, and 23f in infants and children from 6 weeks up to 5 years of age.the use of synflorix should be determined on the basis of official recommendations taking into consideration the impact on pneumococcal diseases in different age groups as well as the variability of the epidemiology in different geographical areas.10.07.2017 בקשה לשינוי משטר מינוןthree-dose primary seriesthe recommended immunisation series to ensure optimal protection consists of four doses, each of 0.5 ml. the primary infant series consists of three doses with the first dose usually given at 2 months of age and with an interval of at least 1 month between doses. the first dose may be given as early as six 6 weeks of age. a booster (fourth) dose is recommended at least 6 months after the last priming primary dose and may be given from the age of 9 months onwards (preferably between 12 and

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - pneumococcal polysaccharide serotype 1; pneumococcal polysaccharide serotype 14; pneumococcal polysaccharide serotype 18c; pneumococcal polysaccharide serotype 19 f; pneumococcal polysaccharide serotype 19a; pneumococcal polysaccharide serotype 23f; pneumococcal polysaccharide serotype 3; pneumococcal polysaccharide serotype 4; pneumococcal polysaccharide serotype 5; pneumococcal polysaccharide serotype 6a; pneumococcal polysaccharide serotype 6b; pneumococcal polysaccharide serotype 7f; pneumococcal polysaccharide serotype 9v - suspension for injection - pneumococcal polysaccharide serotype 23f 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 19 f 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 14 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 9v 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 7f 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 6b 4.4 mcg / 0.5 ml; pneumococcal polysaccharide serotype 5 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 4 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 1 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 3 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 6a 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 18c 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 19a 2.2 mcg / 0.5 ml - pneumococcus, purified polysaccharides antigen conjugated - pneumococcus, purified polysaccharides antigen conjugated - 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 and pneumonia caused by streptococcus pneumoniae in adults ≥18 years of age and the elderly

Singapore - English - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - conjugate of streptococcus pneumoniae type 1 & haemophilus influenzae protein d - injection, suspension - 1 μg ps1; 1.11-1.67 μg pd/dose

European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - pneumococcal polysaccharide serotype 23f, pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 5, pneumococcal polysaccharide serotype 6b, pneumococcal polysaccharide serotype 7f, pneumococcal polysaccharide serotype 9v, pneumococcal polysaccharide serotype 1, pneumococcal polysaccharide serotype 14, pneumococcal polysaccharide serotype 18c, pneumococcal polysaccharide serotype 19f - pneumococcal infections; immunization - vaccines - 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.

Canada - English - Health Canada

glaxosmithkline inc - pneumococcal polysaccharide serotype 1 conjugated to protein d carrier protein; pneumococcal polysaccharide serotype 4 conjugated to protein d carrier protein; pneumococcal polysaccharide serotype 5 conjugated to protein d carrier protein; pneumococcal polysaccharide serotype 6b conjugated to protein d carrier protein; pneumococcal polysaccharide serotype 7f conjugated to protein d carrier protein; pneumococcal polysaccharide serotype 9v conjugated to protein d carrier protein; pneumococcal polysaccharide serotype 14 conjugated to protein d carrier protein; pneumococcal polysacc. serot. 18c conjug. to tetanus toxoid carrier prot.; pneumococcal polysaccharid serot. 19f conjug. to diphtheria toxoid carrier prot.; pneumococcal polysaccharide serotype 23f conjugated to protein d carrier protein - suspension - 1mcg; 3mcg; 1mcg; 1mcg; 1mcg; 1mcg; 1mcg; 3mcg; 3mcg; 1mcg - pneumococcal polysaccharide serotype 1 conjugated to protein d carrier protein 1mcg; pneumococcal polysaccharide serotype 4 conjugated to protein d carrier protein 3mcg; pneumococcal polysaccharide serotype 5 conjugated to protein d carrier protein 1mcg; pneumococcal polysaccharide serotype 6b conjugated to protein d carrier protein 1mcg; pneumococcal polysaccharide serotype 7f conjugated to protein d carrier protein 1mcg; pneumococcal polysaccharide serotype 9v conjugated to protein d carrier protein 1mcg; pneumococcal polysaccharide serotype 14 conjugated to protein d carrier protein 1mcg; pneumococcal polysacc. serot. 18c conjug. to tetanus toxoid carrier prot. 3mcg; pneumococcal polysaccharid serot. 19f conjug. to diphtheria toxoid carrier prot. 3mcg; pneumococcal polysaccharide serotype 23f conjugated to protein d carrier protein 1mcg - vaccines