Canada - English - Health Canada

astrazeneca canada inc - influenza virus type a (h1n1); influenza virus type a (h3n2); influenza virus type b (victoria); influenza virus type b (yamagata) - spray - 32000000ffu; 32000000ffu; 32000000ffu; 32000000ffu - influenza virus type a (h1n1) 32000000ffu; influenza virus type a (h3n2) 32000000ffu; influenza virus type b (victoria) 32000000ffu; influenza virus type b (yamagata) 32000000ffu - vaccines

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] -

Israel - English - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - live attenuated oka/merck strain of varicella-zoster virus - powder and solvent for suspension for injection - live attenuated oka/merck strain of varicella-zoster virus 19400 pfu / 0.65 ml - zoster, live attenuated - zoster, live attenuated - zostavax is a live attenuated virus vaccine indicated for prevention of herpes zoster (shingles) in individuals 50 years of age and older.

European Union - English - EMA (European Medicines Agency)

astrazeneca ab - a/darwin/9/2021 (h3n2) - like strain (a/norway/16606/2021, medi 355293) / a/victoria/2570/2019 (h1n1)pdm09 - like strain (a/victoria/1/2020, medi 340505) / b/austria/1359417/2021 - like strain (b/austria/1359417/2021, medi 355292) / b/phuket/3073/2013 - like strain (b/phuket/3073/2013, medi 306444) - influenza, human - influenza vaccines, influenza, live attenuated - prophylaxis of influenza in children and adolescents from 24 months to less than 18 years of age. the use of fluenz tetra should be based on official recommendations.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

astrazeneca uk ltd - influenza virus live attenuated - spray

Israel - English - Ministry of Health

astrazeneca (israel) ltd - a/darwin/9/2021 (h3n2)-like virus; a/victoria/4897/2022 (h1n1)pdm09-like virus; b/austria/1359417/2021 (b/victoria lineage)-like virus; b/phuket/3073/2013 (b/yamagata lineage)-like virus - nasal spray, suspension - b/phuket/3073/2013 (b/yamagata lineage)-like virus 7 ±0.5 log10 ffu^a / 0.2 ml; a/darwin/9/2021 (h3n2)-like virus 7 ±0.5 log10 ffu^a / 0.2 ml; b/austria/1359417/2021 (b/victoria lineage)-like virus 7 ±0.5 log10 ffu^a / 0.2 ml; a/victoria/4897/2022 (h1n1)pdm09-like virus 7 ±0.5 log10 ffu^a / 0.2 ml - influenza, inactivated, split virus or surface antigen - influenza, purified antigen - flumist quadrivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza a subtype viruses ad type b viruses contained in the vaccine. flumist quadrivalent is approved for use in persons 2 through 49 years of age.

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - live attenuated measles virus; live attenuated mumps virus; live attenuated rubella virus - powder and solvent for solution for injection - live attenuated mumps virus 10^3.7 ccid50; live attenuated rubella virus 10^3.0 ccid50; live attenuated measles virus 10^3.0 ccid50 - rubella, combinations with mumps, live attenuated - rubella, combinations with mumps, live attenuated - priorix is indicated for active immunisation of children from the age of 9 months or older, adolescents and adults against measles, mumps and rubella.

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

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)

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).