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)

merck sharp & dohme b.v.  - pneumococcal polysaccharide conjugate vaccine (adsorbed) - pneumococcal infections - pneumococcus, purified polysaccharides antigen conjugated - vaxneuvance is indicated for 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 less than 18 years of age.vaxneuvance is indicated for active immunisation for the prevention of invasive disease and pneumonia caused by streptococcus pneumoniae in individuals 18 years of age and older. see sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes.the use of vaxneuvance should be in accordance with official recommendations.

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.

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; water for injections; polysorbate 80; diphtheria crm197 protein; succinic acid; sodium chloride - 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.

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

glaxosmithkline australia pty ltd - pneumococcal purified capsular polysaccharides -

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.

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

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 8, pneumococcal polysaccharide serotype 9v, pneumococcal polysaccharide serotype 10a, pneumococcal polysaccharide serotype 11a, pneumococcal polysaccharide serotype 12f, pneumococcal polysaccharide serotype 14, pneumococcal polysaccharide serotype 15b, pneumococcal polysaccharide serotype 18c, pneumococcal polysaccharide serotype 19a, pneumococcal polysaccharide serotype 19f, pneumococcal polysaccharide serotype 22f, pneumococcal polysaccharide serotype 23f, pneumococcal polysaccharide serotype 33f - pneumococcal infections - vaccines - active immunisation for the prevention of invasive disease and pneumonia caused by streptococcus pneumoniae in individuals 18 years of age and older.see sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes.apexxnar should be used in accordance with official recommendations.