Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

pfizer manufacturing belgium nv - pneumococcal polysaccharide conjugate vaccine (pneumococcal polysaccharide serotype 1, 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, pneumococcal polysaccharide serotype 14, pneumococcal polysaccharide serotype 18c, pneumococcal polysaccharide serotype 19a, pneumococcal polysaccharide serotype 19f, pneumococcal polysaccharide serotype 23f) - suspension for injection - 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 4.4mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

pfizer manufacturing belgium n.v. - pneumococcal polysaccharide conjugate vaccine (pneumococcal polysaccharide serotype 1, 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, pneumococcal polysaccharide serotype 14, pneumococcal polysaccharide serotype 18c, pneumococcal polysaccharide serotype 19a, pneumococcal polysaccharide serotype 19f, pneumococcal polysaccharide serotype 23f) - suspension for injection - 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 4.4mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

pharmaniaga lifescience sdn. bhd. - pneumococcal polysaccharide serotype 1; pneumococcal polysaccharide serotype 5; pneumococcal polysaccharide serotype 9v; pneumococcal polysaccharide serotype 14; pneumococcal polysaccharide serotype 19a; pneumococcal polysaccharide serotype 19f; pneumococcal polysaccharide serotype 23f; pneumococcal polysaccharide serotype 7f; pneumococcal polysaccharide serotype 6a; pneumococcal polysaccharide serotype 6b -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

pharmaniaga lifescience sdn. bhd. - pneumococcal polysaccharide serotype 1; pneumococcal polysaccharide serotype 5; pneumococcal polysaccharide serotype 9v; pneumococcal polysaccharide serotype 14; pneumococcal polysaccharide serotype 19a; pneumococcal polysaccharide serotype 19f; pneumococcal polysaccharide serotype 23f; pneumococcal polysaccharide serotype 7f; pneumococcal polysaccharide serotype 6a; pneumococcal polysaccharide serotype 6b -

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - pneumococcal purified capsular polysaccharides, quantity: 2.2 microgram; pneumococcal purified capsular polysaccharides, quantity: 4.4 microgram - injection, suspension - excipient ingredients: aluminium phosphate; succinic acid; sodium chloride; water for injections; polysorbate 80; diphtheria crm197 protein - active immunisation for the prevention of pneumococcal disease caused by streptococcus pneumoniae serotypes 1, 3, 4, 5, 6a, 6b, 7f, 8, 9v, 10a, 11a, 12f, 14, 15b, 18c, 19a, 19f, 22f, 23f, and 33f in individuals from 6 weeks of age and older.,prevenar 20 may not prevent disease caused by s. pneumoniae serotypes that are not contained in the vaccine.,prevenar 20 should be used in accordance with official recommendations.

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

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - pneumococcal polysaccharide serotype 1 2.2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 14 2.2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 18c 2.2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 19a 2.2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 19f 2.2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 23f 2.2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 3 2.2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 4 2.2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 5 2.2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 6a 2.2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 6b 4.4ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 7f 2.2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 9v 2.2ug (conjugated with diphtheria crm 197 protein) - suspension for injection - 0.5 ml - active: pneumococcal polysaccharide serotype 1 2.2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 14 2.2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 18c 2.2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 19a 2.2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 19f 2.2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 23f 2.2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 3 2.2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 4 2.2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 5 2.2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 6a 2.2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 6b 4.4ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 7f 2.2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 9v 2.2ug (conjugated with diphtheria crm 197 protein) excipient: aluminium phosphate polysorbate 80 sodium chloride succinic acid water for injection - active immunisation for the prevention of pneumococcal disease caused by streptococcus pneumoniae serotypes 1, 3, 4, 5, 6a, 6b, 7f, 9v, 14, 18c, 19a, 19f and 23f in adults and children aged more than 6 weeks of age. the use of prevenar 13 should be guided by official recommendations.

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: pfizer, inc.; distributor: n/a - pneumococcal conjugate vaccine, 13-valent (adsorbed) - suspension for injection (im) - formulation: each 0.5 ml dose contains: pneumococcal polysaccharide serotype 1*.....2.2 mcg pneumococcal polysaccharide serotype 3*..............2.2 mcg pneumococcal polysaccharide serotype 4* ......... .............2.2 mcg pneumococcal polysaccharide serotype 5*..............2.2 mcg pneumococcal polysaccharide serotype 6a*............... ...2.2 mcg pneumococcal polysaccharide serotype 6b*........4.4 mcg pneumococcal polysaccharide serotype 7f*..........2.2 mcg pneumococcal polysaccharide serotype 9v* .........2.2 mcg pneumococcal polysaccharide serotype 14*.............2.2mcg pneumococcal polysaccharide serotype 18c*..............2.2 mcg pneumococcal polysaccharide serotype 19a* .....................2.2 mcg pneumococcal polysaccharide serotype 19f*....................2.2 mcg pneumococcal polysaccharide serotype 23f* .....................2.2 mcg *conjugated to crm197 carrier protein and adsorbed on aluminium phosphate (125 mcg aluminum)

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.

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