Uni Eropa - Inggris - 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.

Uni Eropa - Inggris - 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.

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

pfizer australia pty ltd - meningococcal polysaccharide group c, quantity: 5 microgram; meningococcal polysaccharide group y, quantity: 5 microgram; meningococcal polysaccharide group w135, quantity: 5 microgram; meningococcal polysaccharide group a, quantity: 5 microgram; tetanus toxoid, quantity: 44 microgram - injection, powder for - excipient ingredients: sucrose; trometamol hydrochloride - nimenrix is indicated for active immunisation of individuals from 6 weeks of age against invasive meningococcal diseases caused by neisseria meningitidis groups a, c, w-135 and y.

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

glaxosmithkline australia pty ltd - pneumococcal purified capsular polysaccharides -

Malaysia - Inggris - 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 - Inggris - 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 -

Israel - Inggris - 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

Selandia Baru - Inggris - 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.

Selandia Baru - Inggris - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - pneumococcal polysaccharide serotype 1 1ug (conjugated with nthi protein d);  ;  ; pneumococcal polysaccharide serotype 14 1ug (conjugated with nthi protein d);  ;  ; pneumococcal polysaccharide serotype 18c 3ug (conjugated with tetanus toxoid);  ;  ; pneumococcal polysaccharide serotype 19f 3ug (conjugated with diptheria toxoid);  ;  ; pneumococcal polysaccharide serotype 23f 1ug (conjugated with nthi protein d);  ;  ; pneumococcal polysaccharide serotype 4 3ug (conjugated with nthi protein d);  ;  ; pneumococcal polysaccharide serotype 5 1ug (conjugated with nthi protein d);  ;  ; pneumococcal polysaccharide serotype 6b 1ug (conjugated with nthi protein d);  ;  ; pneumococcal polysaccharide serotype 7f 1ug (conjugated with nthi protein d);  ;  ; pneumococcal polysaccharide serotype 9v 1ug (conjugated with nthi protein d);  ;   - suspension for injection - active: pneumococcal polysaccharide serotype 1 1ug (conjugated with nthi protein d)     pneumococcal polysaccharide serotype 14 1ug (conjugated with nthi protein d)     pneumococcal polysaccharide serotype 18c 3ug (conjugated with tetanus toxoid)     pneumococcal polysaccharide serotype 19f 3ug (conjugated with diptheria toxoid)     pneumococcal polysaccharide serotype 23f 1ug (conjugated with nthi protein d)     pneumococcal polysaccharide serotype 4 3ug (conjugated with nthi protein d)     pneumococcal polysaccharide serotype 5 1ug (conjugated with nthi protein d)     pneumococcal polysaccharide serotype 6b 1ug (conjugated with nthi protein d)     pneumococcal polysaccharide serotype 7f 1ug (conjugated with nthi protein d)     pneumococcal polysaccharide serotype 9v 1ug (conjugated with nthi protein d)     excipient: aluminium phosphate diphtheria toxoid, adsorbed haemophilus influenzae protein d sodium chloride tetanus toxoid water for injection - synflorix is indicated for the active immunisation of infants and children from the age of 6 weeks up to 5 years against disease caused by streptococcus pneumoniae vaccine serotypes 1, 4, 5, 6b, 7f, 9v, 14, 18c, 19f, 23f and cross-reactive serotype 19a (including invasive disease, pneumonia and acute otitis media).

Malta - Inggris - Malta Medicines Authority

pfizer hellas s.a. 243 messoghion ave., neo psychiko 15451, athens, greece - neisseria meningitidis, polysaccharide group, tetanus toxoid - suspension for injection - neisseria meningitidis polysaccharide group c tetanus toxoid - vaccines