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).

Uganda - English - National Drug Authority

serum institute of india pvt ltd - live attenuated bovine - human rotavirus reassortant [g1, g2, g3, g4 and g9] - parenteral ordinary vials - ?105.6 ffu / serotype per dose (2 ml)

Singapore - English - HSA (Health Sciences Authority)

msd pharma (singapore) pte. ltd. - human-bovine rotavirus g1; human-bovine rotavirus g2; human-bovine rotavirus g3; human-bovine rotavirus g4; human-bovine rotavirus p1 - solution - 2.2 x exponential 6 infectious units - human-bovine rotavirus g1 2.2 x exponential 6 infectious units; human-bovine rotavirus g2 2.8 x exponential 6 infectious units; human-bovine rotavirus g3 2.2 x exponential 6 infectious units; human-bovine rotavirus g4 2.0 x exponential 6 infectious units; human-bovine rotavirus p1 2.3 x exponential 6 infectious units

Panama - English - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

glaxosmithkline biologicals, s.a. - rotavirus humano, vivo atenuado, cepa rix4414 - rotavirus humano, vivo atenuado, cepa rix4414....no menos de 10x6 ccid50

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

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.

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

glaxosmithkline australia pty ltd - rotavirus -

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

bharat biotech international limited, india - rotavirus vaccine - freeze dried lyophilised vaccine - 5 ml/10 dose. 0.5 ml (5 drops) contains nlt 105.0 ffu of rotavirus 116e bulk, neomycin sulfate 15 µg, kanamycin acid sulphate 15 µg

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

sm pharmaceuticals sdn. bhd. - live attenuated bovine-human rotavirus reassortant [g1, g2, g3, g4 and g9] -