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).

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

Kenya - English - Pharmacy and Poisons Board

msd (pty) ltd 117 16th road halfway house southafrica - rotavirus live reassortant virus g1, g2, g3, g4… - oral solution in single-dose container - reassortant g1: 2.2 times 106 infectious units,… - viral vaccines: rotavirusdiarrhea vaccines

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - rotavirus reassortant strain g1 2.2e+006 [iu] (nlt, at expiry); rotavirus reassortant strain g2 2.8e+006 [iu] (nlt, at expiry); rotavirus reassortant strain g3 2.2e+006 [iu] (nlt, at expiry); rotavirus reassortant strain g4 2e+006 [iu] (nlt, at expiry); rotavirus reassortant strain p1 2.3e+006 [iu] (nlt, at expiry) - oral solution - 2 ml - active: rotavirus reassortant strain g1 2.2e+006 [iu] (nlt, at expiry) rotavirus reassortant strain g2 2.8e+006 [iu] (nlt, at expiry) rotavirus reassortant strain g3 2.2e+006 [iu] (nlt, at expiry) rotavirus reassortant strain g4 2e+006 [iu] (nlt, at expiry) rotavirus reassortant strain p1 2.3e+006 [iu] (nlt, at expiry) excipient: rotavirus diluent & lpkm-3 (from actives) to approx 0.3 ml. includes animal materials as below. monobasic sodium phosphate monohydrate polysorbate 80 purified water sodium citrate dihydrate sodium hydroxide sucrose - rotateq is an oral pentavalent vaccine indicated for the prevention of rotavirus gastroenteritis in infants and children caused by the serotypes g1, g2, g3, g4, and g-serotypes that contain p1a[8] (e.g., g9). rotateq may be administered as early as six weeks of age.

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] -

European Union - English - EMA (European Medicines Agency)

medimmune llc - reassortant influenza virus (live attenuated) of the following strains:a/california/7/2009 (h1n1)pdm09 like strain, a/victoria/361/2011 (h3n2) like strain, b/massachusetts/2/2012 like strain - influenza, human; immunization - vaccines - prophylaxis of influenza in individuals 24 months to less than 18 years of age.the use of fluenz should be based on official recommendations.

European Union - English - EMA (European Medicines Agency)

astrazeneca ab - reassortant influenza virus (live attenuated) of the following strain: a/vietnam/1203/2004 (h5n1) strain - influenza, human - vaccines - prophylaxis of influenza in an officially declared pandemic situation in children and adolescents from 12 months to less than 18 years of age.pandemic influenza vaccine h5n1 astrazeneca should be used in accordance with official guidance

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

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 -

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