Singapore - English - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - recombinant varicella zoster virus glycoprotein e - injection, powder, lyophilized, for liposomal suspension - recombinant varicella zoster virus glycoprotein e 50mcg/0.5ml

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - hepatitis b surface antigen, recombinant 20 µg/ml; hepatitis b surface antigen, recombinant 20 µg/ml - suspension for injection - 10 mcg/0.5ml - active: hepatitis b surface antigen, recombinant 20 µg/ml excipient: aluminium hydroxide dibasic sodium phosphate dihydrate monobasic sodium phosphate dihydrate phenoxyethanol sodium chloride thiomersal water for injection active: hepatitis b surface antigen, recombinant 20 µg/ml excipient: aluminium hydroxide dibasic sodium phosphate dihydrate monobasic sodium phosphate dihydrate sodium chloride water for injection - engerix-b is indicated for active immunization against hepatitis b virus infection.

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - hepatitis b surface antigen, recombinant 20 µg/ml; hepatitis b surface antigen, recombinant 20 µg/ml - suspension for injection - 20 mcg/ml - active: hepatitis b surface antigen, recombinant 20 µg/ml excipient: aluminium hydroxide dibasic sodium phosphate dihydrate monobasic sodium phosphate dihydrate phenoxyethanol sodium chloride thiomersal water for injection active: hepatitis b surface antigen, recombinant 20 µg/ml excipient: aluminium hydroxide dibasic sodium phosphate dihydrate monobasic sodium phosphate dihydrate sodium chloride water for injection - engerix-b is indicated for active immunization against hepatitis b virus infection.

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - diphtheria toxoid, adsorbed 30 [iu]; pertactin 8ug;  ; pertussis filamentous haemagglutinin 25ug;  ; pertussis toxoid, adsorbed 25ug;  ; tetanus toxoid, adsorbed 40 [iu]; diphtheria toxoid, adsorbed 30 [iu]; pertactin 8ug; pertussis filamentous haemagglutinin 25ug; pertussis toxoid, adsorbed 25ug; tetanus toxoid, adsorbed 40 [iu] - suspension for injection - 0.5 ml - active: diphtheria toxoid, adsorbed 30 [iu] pertactin 8ug   pertussis filamentous haemagglutinin 25ug   pertussis toxoid, adsorbed 25ug   tetanus toxoid, adsorbed 40 [iu] excipient: aluminium as aluminium hydroxide & phosphate sodium chloride water for injection active: diphtheria toxoid, adsorbed 30 [iu] pertactin 8ug pertussis filamentous haemagglutinin 25ug pertussis toxoid, adsorbed 25ug tetanus toxoid, adsorbed 40 [iu] excipient: aluminium as aluminium hydroxide & phosphate phenoxyethanol polysorbate 80 sodium chloride water for injection - infanrix (dtpa) is indicated for active primary immunisation against diptheria, tetanus and pertussis. infanrix is indicated as fourth and/or fifth dose for children from 15 months of age up to and including 6 years of age who have previously been immunised with three or four doses of diphtheria, tetanus and pertussis (whole cell or acellular) vaccine.

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - diphtheria toxoid, adsorbed 60 iu/ml; pertactin 16 µg/ml;  ; pertussis filamentous haemagglutinin 50 µg/ml;  ; pertussis toxoid, adsorbed 50 µg/ml;  ; polio virus type 1 80 dagu/ml;  ; polio virus type 2 16 dagu/ml;  ; polio virus type 3 64 dagu/ml;  ; tetanus toxoid, adsorbed 80 iu/ml - suspension for injection - 0.5 ml - active: diphtheria toxoid, adsorbed 60 iu/ml pertactin 16 µg/ml   pertussis filamentous haemagglutinin 50 µg/ml   pertussis toxoid, adsorbed 50 µg/ml   polio virus type 1 80 dagu/ml   polio virus type 2 16 dagu/ml   polio virus type 3 64 dagu/ml   tetanus toxoid, adsorbed 80 iu/ml excipient: aluminium hydroxide neomycin sulfate polymyxin b sulfate sodium chloride water for injection - infanrix®-ipv is indicated for active primary immunisation against diphtheria, tetanus, pertussis, and poliomyelitis. infanrix®-ipv is also indicated as a booster dose for children who have previously been immunised with dtp and polio antigens.

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - measles vaccine, schwarz strain 1000 ccid50 (not less than); mumps virus, live attenuated, rit 4385 5012 ccid50 (not less than);  ; rubella virus, wistar ra27/3 strain 1000 ccid50 (not less than) - powder for injection with diluent - 0.5 ml - active: measles vaccine, schwarz strain 1000 ccid50 (not less than) mumps virus, live attenuated, rit 4385 5012 ccid50 (not less than)   rubella virus, wistar ra27/3 strain 1000 ccid50 (not less than) excipient: amino acids lactose mannitol sorbitol water for injection - priorix is indicated for the active immunisation against measles, mumps and rubella.

New Zealand - English - 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).

Singapore - English - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - hpv-16 l1; hpv-18 l1 - injection, suspension - 20 μg/0.5ml - hpv-16 l1 20 μg/0.5ml; hpv-18 l1 20μg/0.5ml

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

glaxosmithkline australia pty ltd - varicella vaccine - live -

European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - human papillomavirus1 type 16 l1 protein, human papillomavirus type 18 l1 protein - papillomavirus infections; uterine cervical dysplasia; immunization - vaccines - cervarix is a vaccine for use from the age of 9 years for the prevention of premalignant ano-genital lesions (cervical, vulvar, vaginal and anal) and cervical and anal cancers causally related to certain oncogenic human papillomavirus (hpv) types. see sections 4.4 and 5.1 for important information on the data that support this indication.the use of cervarix should be in accordance with official recommendations.