Singapore - English - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - diphtheria toxoid; filamentous haemagglutinin; hepatitis b surface antigen (purified); hib purified capsular polysaccharide bound to tetanus toxoid; pertactin (69 kda omp); pertussis toxoid; poliovirus type 1 (inactivated); poliovirus type 2 (inactivated); poliovirus type 3 (inactivated) - injection - min 30 iu/0.5 ml - diphtheria toxoid min 30 iu/0.5 ml; filamentous haemagglutinin 25 mcg/0.5 ml; hepatitis b surface antigen (purified) 10 mcg/0.5 ml; hib purified capsular polysaccharide bound to tetanus toxoid 10 mcg/0.5 ml; pertactin (69 kda omp) 8 mcg/0.5 ml; pertussis toxoid 25 mcg/0.5 ml; poliovirus type 1 (inactivated) 40 du/0.5 ml; poliovirus type 2 (inactivated) 8 du/0.5 ml; poliovirus type 3 (inactivated) 32 du/0.5 ml

European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - hepatitis a virus (inactivated), hepatitis b surface antigen - immunization; hepatitis b; hepatitis a - vaccines - twinrix paediatric is indicated for use in non-immune infants, children and adolescents from one year up to and including 15 years who are at risk of both hepatitis-a and hepatitis-b infection.

European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - hepatitis a virus (inactivated), hepatitis b surface antigen - hepatitis b; hepatitis a; immunization - vaccines - twinrix adult is indicated for use in non immune adults and adolescents 16 years of age and above who are at risk of both hepatitis a and hepatitis b infection.

European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a.  - respiratory syncytial virus recombinant glycoprotein f stabilised in the pre-fusion conformation (rsvpref3) produced in chinese hamster ovary (cho) cells by recombinant dna technology - respiratory syncytial virus infections - vaccines - arexvy is indicated for active immunisation for the prevention of lower respiratory tract disease (lrtd) caused by respiratory syncytial virus in adults 60 years of age and older.the use of this vaccine should be in accordance with official recommendations. 

Singapore - English - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - conjugate of streptococcus pneumoniae type 1 & haemophilus influenzae protein d; conjugate of streptococcus pneumoniae type 14 and haemophilus influenzae protein d; conjugate of streptococcus pneumoniae type 18c and tetanus toxoid; conjugate of streptococcus pneumoniae type 19f and diphtheria toxoid; conjugate of streptococcus pneumoniae type 23f and haemophilus influenzae protein d; conjugate of streptococcus pneumoniae type 4 and haemophilus influenzae protein d; conjugate of streptococcus pneumoniae type 5 and haemophilus influenzae protein d; conjugate of streptococcus pneumoniae type 6b and haemophilus influenzae protein d; conjugate of streptococcus pneumoniae type 7f and haemophilus influenzae protein d; conjugate of streptococcus pneumoniae type 9v and haemophilus influenzae protein d; diphtheria toxoid (dt) carrier protein; polysaccharide (ps); protein-d (pd) carrier protein (derived from non-typeable haemophilus influenzae); tetanus toxoid (tt) carrier protein - injection, suspension - 1 μg ps1; 1.11-1.67 μg pd/dose - conjugate of streptococcus pneumoniae type 1 & haemophilus influenzae protein d 1 μg ps1; 1.11-1.67 μg pd/dose; conjugate of streptococcus pneumoniae type 14 and haemophilus influenzae protein d 1 μg ps14; 1.00-1.82 μg pd/dose; conjugate of streptococcus pneumoniae type 18c and tetanus toxoid 3 μg ps18c; 5.45-10.00 μg tt/dose; conjugate of streptococcus pneumoniae type 19f and diphtheria toxoid 3 μg ps19f; 3.33-6.00 μg dt/dose; conjugate of streptococcus pneumoniae type 23f and haemophilus influenzae protein d 1 μg ps23f; 0.39-0.74 μg pd/dose; conjugate of streptococcus pneumoniae type 4 and haemophilus influenzae protein d 3 μg ps4; 3.33-6.67 μg pd/dose; conjugate of streptococcus pneumoniae type 5 and haemophilus influenzae protein d 1 μg ps5; 0.67-1.25 μg pd/dose; conjugate of streptococcus pneumoniae type 6b and haemophilus influenzae protein d 1 μg ps6b; 0.56-0.95 μg pd/dose; conjugate of streptococcus pneumoniae type 7f and haemophilus influenzae protein d 1 μg ps7f; 0.87-1.43 μg pd/dose; conjugate of streptococcus pneumoniae type 9v and haemophilus influenzae protein d 1 μg ps9v; 1.00-1.82 μg pd/dose; diphtheria toxoid (dt) carrier protein 3-6 μg dt/dose (total dt content); polysaccharide (ps) 16 μg/dose (total ps content); protein-d (pd) carrier protein (derived from non-typeable haemophilus influenzae) 9-16 μg pd/dose (total pd content); tetanus toxoid (tt) carrier protein 5-10 μg/dose (total tt content)

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

glaxosmithkline biologicals s.a. - human papillomavirus type 16 l1 protein, human papillomavirus type 18 l1 protein - suspension for injection - 20mcg/dose+ 20mcg/dose

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

glaxosmithkline biologicals s.a. - human papillomavirus type 16 l1 protein, human papillomavirus type 18 l1 protein - suspension for injection - 20mcg/dose+ 20mcg/dose

European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - hepatitis a virus (inactivated), hepatitis b surface antigen - hepatitis b; hepatitis a; immunization - vaccines - ambirix is for use in non-immune persons from one year up to and including 15 years of age for protection against hepatitis-a and hepatitis-b infection.protection against hepatitis-b infections may not be obtained until after the second dose.therefore:ambirix should be used only when there is a relatively low risk of hepatitis-b infection during the vaccination course;it is recommended that ambirix should be administered in settings where completion of the two-dose vaccination course can be assured.

European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - split influenza virus, inactivated, containing antigen: a/vietnam/1194/2004 (h5n1) like strain used (nibrg-14) - influenza, human; immunization; disease outbreaks - vaccines - active immunisation against h5n1 subtype of influenza a virus.this indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of vaccine prepared from a/vietnam/1194/2004 nibrg-14 (h5n1) (see section 5.1).prepandemic influenza vaccine (h5n1) (split virion, inactivated, adjuvanted) glaxosmithkline biologicals 3.75 µg should be used in accordance with official guidance.

United States - English - NLM (National Library of Medicine)

glaxosmithkline biologicals sa - clostridium tetani toxoid antigen (formaldehyde inactivated) (unii: k3w1n8yp13) (clostridium tetani toxoid antigen (formaldehyde inactivated) - unii:k3w1n8yp13), corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) (unii: irh51qn26h) (corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) - unii:irh51qn26h), bordetella pertussis toxoid antigen (formaldehyde, glutaraldehyde inactivated) (unii: qsn5xo8zsu) (bordetella pertussis toxoid antigen (formaldehyde, glutaraldehyde inactivated) - unii:qsn5xo8zsu), bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated) (unii: 8c367iy4ey) (bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated) - unii:8c367iy4ey), bordetella pertussis pertactin antigen (formaldehyde inactivated) (unii: i05o535nv6) (bordetella pertussis pertactin antigen (formaldehyde inactivated) - unii:i05o535nv6) - clostridium tetani toxoid antigen (formaldehyde inactivated) 10 [iu] in 0.5 ml - infanrix is indicated for active immunization against diphtheria, tetanus, and pertussis as a 5-dose series in infants and children aged 6 weeks through 6 years (prior to the seventh birthday). severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, or pertussis-containing vaccine, or to any component of infanrix is a contraindication [see description (11)] . because of the uncertainty as to which component of the vaccine might be responsible, no further vaccination with any of these components should be given. alternatively, such individuals may be referred to an allergist for evaluation if immunization with any of these components is being considered. encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous dose of a pertussis-containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis-containing vaccine, including infanrix. progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy, is a contraindication to administration of any pertussis-containing vaccine, including infanrix. pertussis vaccine should not be administered to individuals with these conditions until a treatment regimen has been established and the condition has stabilized. safety and effectiveness of infanrix in infants aged younger than 6 weeks and children aged 7 to 16 years have not been established. infanrix is not approved for use in these age groups.