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

merck sharp & dohme (australia) pty ltd - rotavirus g2 human-bovine reassortant, quantity: 1400000 infectious unit/ml; rotavirus g3 human-bovine reassortant, quantity: 1100000 infectious unit/ml; rotavirus g1 human-bovine reassortant, quantity: 1100000 infectious unit/ml; rotavirus g4 human-bovine reassortant, quantity: 1000000 infectious unit/ml; rotavirus p1 [8] human-bovine reassortant, quantity: 1150000 infectious unit/ml - oral liquid - excipient ingredients: polysorbate 80; sucrose; sodium citrate dihydrate; sodium hydroxide; monobasic sodium phosphate; glucose monohydrate; sodium ascorbate; sodium chloride; ammonium metavanadate; calcium chloride dihydrate; cupric sulfate pentahydrate; ferric nitrate nonahydrate; ferrous sulfate heptahydrate; magnesium chloride hexahydrate; dried magnesium sulfate; manganese sulfate tetrahydrate; ammonium molybdate; potassium chloride; sodium acetate; sodium bicarbonate; dibasic sodium phosphate; zinc sulfate heptahydrate; alanine; arginine hydrochloride; asparagine; aspartic acid; cysteine hydrochloride; cystine dihydrochloride; glutamic acid; glycine; histidine hydrochloride monohydrate; hydroxyproline; isoleucine; leucine; lysine hydrochloride; methionine; phenylalanine; proline; serine; threonine; tryptophan; tyrosine disodium; valine; biotin; ergocalciferol; choline chloride; folic acid; inositol; menadione; nicotinamide; nicotinic acid; aminobenzoic acid; calcium pantothenate; pyridoxal hydrochloride; pyridoxine hydrochloride; retinol acetate; riboflavine; dl-alpha-tocopheryl phosphate disodium; thiamine hydrochloride; cyanocobalamin; adenine sulfate dihydrate; adenosine triphosphate disodium; adenosine monophosphate; cholesterol; deoxyribose; glutathione; guanine hydrochloride; sodium hypoxanthine; linoleic acid; alpha lipoic acid; phenolsulfonphthalein; putrescine dihydrochloride; sodium pyruvate; ribose; thymidine; thymine; uracil; sodium xanthine; monoethanolamine; 2-mercaptoethanol; adenosine; uridine; cytidine; guanosine; dexamethasone; epidermal growth factor; hydrocortisone; insulin; alprostadil; liothyronine; ascorbic acid; magnesium sulfate heptahydrate; monobasic sodium phosphate monohydrate; zinc sulfate; arginine; cysteine; cystine; histidine; lysine; tyrosine; adenosine triphosphate; guanine; putrescine - rotateq is indicated for the prevention of rotavirus gastroenteritis (see clinical trials).

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] -

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: faberco life sciences inc.; distributor: n/a - rotavirus vaccine (live, attenuated) - freeze-dried powder for oral suspension - formulation: after reconstitution, each dose (2.5 ml) contains: live attenuated bovine-human rotavirus reassortant [g1, g2, g3, g4 and g9]* >10^5.6 ffu/serotype *grown on vero cells

Uganda - English - National Drug Authority

serum institute of india ltd. - live attenuated bovine - human rotavirus reassortant [g1, g2, g3, g4 and g9] - parenteral ordinary vials - ?105.6 ffu / serotype

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)

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: faberco life sciences, inc.; distributor: faberco life sciences, inc. - rotavirus vaccine, (live attenuated) - oral suspension - formulation: each dose (2 ml) contains: live, attenuated bovine - human rotavirus reassortant [g1, g2, g3, g4, and g9]* *grown on vero cells **ffu= focus-forming unit ***ccid= cell culture infectious disease ≥105.6 ffu**/serotype (nlt 6.30 log10 ccid 50*** per dose)

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

merck sharp & dohme australia pty ltd - rotavirus g2 human-bovine reassortant; rotavirus g1 human-bovine reassortant; rotavirus g4 human-bovine reassortant; rotavirus g3 human-bovine reassortant; rotavirus p1 [8] human-bovine reassortant -

Canada - English - Health Canada

merck canada inc - human-bovine rotavirus reassortant type g1; human-bovine rotavirus reassortant type g2; human-bovine rotavirus reassortant type g3; human-bovine rotavirus reassortant type g4; human-bovine rotavirus reassortant type p1(8) - solution - 2210000unit; 2840000unit; 2220000unit; 2040000unit; 2290000unit - human-bovine rotavirus reassortant type g1 2210000unit; human-bovine rotavirus reassortant type g2 2840000unit; human-bovine rotavirus reassortant type g3 2220000unit; human-bovine rotavirus reassortant type g4 2040000unit; human-bovine rotavirus reassortant type p1(8) 2290000unit - vaccines

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

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

serum institute of india pvt. ltd. (siipl), india - live attenuated rotavirus vaccine - lyophilized powder for reconstitution - 10^5.6 ffu/serotype