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.

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 - vaccines - prophylaxis of influenza in an officially declared pandemic situation. pandemic influenza vaccine should be used in accordance with official guidance.

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, - prophylaxis of influenza in an officially declared pandemic situation. pandemic influenza vaccine should be used in accordance with official guidance.,

Singapore - English - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - live attenuated measles virus (schwarz strain); live attenuated mumps virus (rit4385 strain); live attenuated rubella virus (wistar ra 27/3 strain); live attenuated varicella virus (oka strain) - injection, powder, lyophilized, for solution - ≥ 10 3.0 ccid50 /dose - live attenuated measles virus (schwarz strain) ≥ 10³ ccid50/dose; live attenuated mumps virus (rit4385 strain) ≥ 10⁴·⁴ ccid50/dose; live attenuated rubella virus (wistar ra 27/3 strain) ≥ 10³ ccid50/dose; live attenuated varicella virus (oka strain) ≥ 10³·³ pfu/dose

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

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 - influenza virus a/california/7/2009 (h1n1) - like strain 30 µg/ml (a/christchurch/16/2010 (nib-74xp) (15 µg ha)); influenza virus a/hong kong/4801/2014 (h3n2) - like strain 30 µg/ml (a/hong kong/4801/2014, nymc x-263b (15 µg ha)); influenza virus b/brisbane/60/2008 - like strain 30 µg/ml (b/brisbane/60/2008 (15 µg ha)) - suspension for injection - active: influenza virus a/california/7/2009 (h1n1) - like strain 30 µg/ml (a/christchurch/16/2010 (nib-74xp) (15 µg ha)) influenza virus a/hong kong/4801/2014 (h3n2) - like strain 30 µg/ml (a/hong kong/4801/2014, nymc x-263b (15 µg ha)) influenza virus b/brisbane/60/2008 - like strain 30 µg/ml (b/brisbane/60/2008 (15 µg ha)) excipient: commercial light duty detergent d-alpha-tocopheryl acid succinate dibasic sodium phosphate dodecahydrate formaldehyde gentamicin sulfate magnesium chloride hexahydrate monobasic potassium phosphate potassium chloride sodium chloride sodium deoxycholate sucrose water for injection - fluarix is indicated for prophylaxis against influenza in adults and children older than six months of age.

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - hepatitis a vaccine 1440 eu/ml;  ; hepatitis a vaccine 1440 eu/ml - suspension for injection - 1440 eu/ml - active: hepatitis a vaccine 1440 eu/ml   excipient: aluminium hydroxide amino acids dibasic sodium phosphate dihydrate monobasic potassium phosphate polysorbate 20 potassium chloride sodium chloride active: hepatitis a vaccine 1440 eu/ml excipient: aluminium hydroxide amino acids dibasic sodium phosphate dihydrate monobasic potassium phosphate phenoxyethanol polysorbate 20 potassium chloride sodium chloride - havrix is indicated for active immunisation against hav infection in subjects at risk of exposure to hav. havrix will not prevent hepatitis infection caused by other agents such as hepatitis b virus, hepatitis c virus, hepatitis e virus or other pathogens known to infect the liver. in areas of low and intermediate prevalence of hepatitis a, immunisation with havrix is particularly recommended in subjects who are, or will be, at increased risk of infection.

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - hepatitis a vaccine 1440 eu/ml equivalent to 720 eu/0.5 ml;  ; hepatitis a vaccine 1440 eu/ml equivalent to 720 eu/0.5ml - suspension for injection - 720 elisa u/0.5ml - active: hepatitis a vaccine 1440 eu/ml equivalent to 720 eu/0.5 ml   excipient: aluminium hydroxide amino acids dibasic sodium phosphate dihydrate monobasic potassium phosphate polysorbate 20 potassium chloride sodium chloride active: hepatitis a vaccine 1440 eu/ml equivalent to 720 eu/0.5ml excipient: aluminium hydroxide amino acids dibasic sodium phosphate dihydrate monobasic potassium phosphate phenoxyethanol polysorbate 20 potassium chloride sodium chloride - havrix is indicated for active immunisation against hav infection in subjects at risk of exposure to hav. havrix will not prevent hepatitis infection caused by other agents such as hepatitis b virus, hepatitis c virus, hepatitis e virus or other pathogens known to infect the liver. in areas of low and intermediate prevalence of hepatitis a, immunisation with havrix is particularly recommended in subjects who are, or will be, at increased risk of infection.