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

glaxosmithkline australia pty ltd - rotavirus -

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - rotavirus vaccine 1e+006 ccid50 (rix4414 strain, grown in vero cells) - powder with diluent for oral suspension - 1e+006 ccid50 - active: rotavirus vaccine 1e+006 ccid50 (rix4414 strain, grown in vero cells) excipient: amino acids dextran 40 dulbecco's modified eagle medium sorbitol sucrose calcium carbonate water for injection xanthan gum - rotarix is indicated for the prevention of rotavirus gastroenteritis

Israel - English - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - rotavirus g1 reassortant; rotavirus g2 reassortant; rotavirus g3 reassortant; rotavirus g4 reassortant; rotavirus p1a[8] reassortant - oral solution - rotavirus p1a[8] reassortant 2.3 x10 ^6 iu/dose; rotavirus g2 reassortant 2.8 x10 ^6 iu/dose; rotavirus g4 reassortant 2.0 x10^ 6 iu/dose; rotavirus g3 reassortant 2.2 x10 ^6 iu/dose; rotavirus g1 reassortant 2.2 x10 ^6 iu/dose - rota virus diarrhea vaccines - rotateq is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by types g1, g2, g3, g4, and g9 when administered as a 3-dose series to infants between the ages of 6 to 32 weeks. the first dose of rotateq should be administered between 6 and 12 weeks of age

Singapore - English - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - human rotavirus, live, attenuated, rix 4414 strain - suspension - not less than 10⁶ ccid₅₀/dose (1.5 ml) - human rotavirus, live, attenuated, rix 4414 strain not less than 10⁶ ccid₅₀/dose (1.5 ml)

Singapore - English - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - human rotavirus, live, attenuated, rix 4414 strain - suspension - not less than 10⁶ ccid₅₀/dose (1.5 ml) - human rotavirus, live, attenuated, rix 4414 strain not less than 10⁶ ccid₅₀/dose (1.5 ml)

European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - human rotavirus, live attenuated - immunization; rotavirus infections - vaccines - rotarix is indicated for the active immunisation of infants aged 6 to 24 weeks for prevention of gastroenteritis due to rotavirus infection.the use of rotarix should be based on official recommendation.

Canada - English - Health Canada

basf corporation - sodium chlorite; sodium dichloroisocyanurate - tablet - 20.8%; 7% - sodium chlorite 20.8%; sodium dichloroisocyanurate 7% - disinfectants (for agents used on object)

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

glaxosmithkline australia pty ltd - rotavirus, quantity: 1000000 ccid50/dose - oral liquid, suspension - excipient ingredients: sucrose; water for injections; adipic acid; sodium hydroxide; glucose monohydrate; sodium chloride; potassium chloride; magnesium sulfate heptahydrate; ferric nitrate nonahydrate; dibasic sodium phosphate dihydrate; sodium pyruvate; folic acid; calcium pantothenate; inositol; choline chloride; nicotinamide; pyridoxine hydrochloride; thiamine hydrochloride; riboflavine; cystine; tyrosine; arginine; glycine; histidine; isoleucine; leucine; lysine; methionine; phenylalanine; threonine; tryptophan; serine; valine; glutamine; calcium chloride dihydrate; sodium bicarbonate - rotarix is indicated for the prevention of rotavirus gastroenteritis. see section 5.1 pharmacodynamic properties - clinical trials.

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

glaxosmithkline australia pty ltd - rotavirus, quantity: 1000000 ccid50/dose - oral liquid, suspension - excipient ingredients: sucrose; water for injections; adipic acid; sodium hydroxide; glucose monohydrate; sodium chloride; potassium chloride; magnesium sulfate heptahydrate; ferric nitrate nonahydrate; dibasic sodium phosphate dihydrate; sodium pyruvate; folic acid; calcium pantothenate; inositol; choline chloride; nicotinamide; pyridoxine hydrochloride; thiamine hydrochloride; riboflavine; cystine; tyrosine; arginine; glycine; histidine; isoleucine; leucine; lysine; methionine; phenylalanine; threonine; tryptophan; serine; valine; glutamine; calcium chloride dihydrate; sodium bicarbonate - rotarix is indicated for the prevention of rotavirus gastroenteritis (see clinical trials).

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

glaxosmithkline australia pty ltd - rotavirus, quantity: 1000000 ccid50/dose - oral liquid, suspension - excipient ingredients: sucrose; water for injections; adipic acid; sodium hydroxide; glucose monohydrate; sodium chloride; potassium chloride; magnesium sulfate heptahydrate; ferric nitrate nonahydrate; dibasic sodium phosphate dihydrate; sodium pyruvate; folic acid; calcium pantothenate; inositol; choline chloride; nicotinamide; pyridoxine hydrochloride; thiamine hydrochloride; riboflavine; cystine; tyrosine; arginine; glycine; histidine; isoleucine; leucine; lysine; methionine; phenylalanine; threonine; tryptophan; serine; valine; glutamine; calcium chloride dihydrate; sodium bicarbonate - rotarix is indicated for the prevention of rotavirus gastroenteritis (see clinical trials).