Philippines - English - FDA (Food And Drug Administration)

pfizer, inc.; distributor: pfizer, inc. - pneumococcal conjugate vaccine, 13-valent (adsorbed) [see formulation on reverse side] - suspension for injection (im) - 0.5 ml

European Union - English - EMA (European Medicines Agency)

pfizer europe ma eeig - 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 - pneumococcal infections; immunization - vaccines - 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 caused by streptococcus pneumoniae in adults ≥18 years of age and the elderly.see sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes.the use of prevenar 13 should be determined on the basis of official recommendations taking into consideration the risk of invasive disease in different age groups, underlying comorbidities 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

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.

Malta - English - Medicines Authority

merck sharp & dohme b.v. waarderweg 39, haarlem noord-holland, 2031 bn, netherlands - pneumococcal polysaccharide, serotype, conjugated to, crm, b conjugated, to crm, f conjugated, n conjugated, v conjugated, a conjugated - solution for injection in a pre-filled syringe - pneumococcal polysaccharide serotype 3 conjugated to crm197 25 µg pneumococcal polysaccharide serotype 5 conjugated to crm197 25 µg pneumococcal polysaccharide serotype 6b conjugated to crm197 25 µg pneumococcal polysaccharide serotype 7f conjugated to crm197 25 µg pneumococcal polysaccharide serotype 8 conjugated to crm197 25 µg pneumococcal polysaccharide serotype 9n conjugated to crm197 25 µg pneumococcal polysaccharide serotype 9v conjugated to crm197 25 µg pneumococcal polysaccharide serotype 10a conjugated to crm197 25 µg pneumococcal polysaccharide serotype 11a conjugated to crm197 25 µg pneumococcal polysaccharide serotype 12f conjugated to crm197 25 µg pneumococcal polysaccharide serotype 14 conjugated to crm197 25 µg pneumococcal polysaccharide serotype 15b conjugated to crm197 25 µg pneumococcal polysaccharide serotype 17f conjugated to crm197 25 µg pneumococcal polysaccharide serotype 17f conjugated to crm197 25 µg pneumococcal polysaccharide serotype 19f conjugated to crm197 25 µg pneumococcal polysaccharide serotype 19a conjugated to crm197 25 µg pneumococcal polysaccharide serotype 20 conjugated to crm197 25 µg pneumococcal polysaccharide serotype 22f conjugated to crm197 25 µg pneumococcal polysaccharide serotype 23f conjugated to crm197 25 µg pneumococcal polysaccharide serotype 33f conjugated to crm197 25 µg pneumococcal polysaccharide serotype 1 conjugated to crm197 25 µg pneumococcal polysaccharide serotype 2 conjugated to crm197 25 µg - vaccines

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)

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - pneumococcal polysaccharide vaccine 50 µg/ml (25mcg/dose of each of 23 named pneumococcal polysaccharides) - solution for injection - active: pneumococcal polysaccharide vaccine 50 µg/ml (25mcg/dose of each of 23 named pneumococcal polysaccharides) excipient: phenol sodium chloride water for injection - pneumovax 23 is indicated for vaccination against pneumococcal disease caused by those pneumococcal types included in the vaccine.

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.

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.

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

merck sharp & dohme (australia) pty ltd - pneumococcal purified capsular polysaccharides, quantity: 50 microgram/ml - injection, solution - excipient ingredients: water for injections; phenol; sodium chloride - pneumovax 23 is indicated for immunisation of individuals in the following situations: all individuals over the age of 65 years; individuals with asplenia, either functional or anatomical, including sickle cell disease, in persons more than 2 years of age; where possible the vaccine should be given at least 14 days before splenectomy; immunocompromised patients at increased risk of pneumococcal disease (eg patients with hiv infection before the development of aids, nephrotic syndrome, multiple myeloma, lymphoma, hodgkin's disease and organ transplantation); aboriginal and torres strait islander people over 50 years of age; immunocompetent persons at increased risk of complications from pneumococcal disease because of chronic illness (eg chronic cardiac, renal or pulmonary disease, diabetes mellitus, alcoholism and cirrhosis); patients with cerebrospinal fluid leaks. in australia, the national health and medical research council (nhmrc) currently recommends the vaccination of tobacco smokers with the 23-valent