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.

Uganda - English - National Drug Authority

intervet south africa (pty) ltd - live,attenuated, infectious bursal disease (gumboro disease) virus, strain d78 - oral liquid ordinary other solid special forms - at least 4.0 log10 tcid50 of infectious bursal disease (gumboro) virus strain d78 (or ?10^4.0 tcid50/dose)

United Kingdom - English - VMD (Veterinary Medicines Directorate)

zoetis uk limited - infectious bursal disease virus - lyophilisate for oculonasal suspension/use in drinking water - live viral vaccine - chickens

United Kingdom - English - VMD (Veterinary Medicines Directorate)

boehringer ingelheim animal health uk ltd - infectious bursal disease virus - powder for oral solution - live viral vaccine - chickens

United Kingdom - English - VMD (Veterinary Medicines Directorate)

laboratorios hipra sa - infectious bursal disease virus - lyophilisate for oral suspension - live viral vaccine - chickens

Ireland - English - HPRA (Health Products Regulatory Authority)

ceva-phylaxia veterinary biologicals co. ltd - avian infectious bursal disease virus, live - concentrate and solvent for suspension for injection - . - avian infectious bursal disease virus (gumboro disease)

United Kingdom - English - VMD (Veterinary Medicines Directorate)

genera inc. - infectious bursal disease virus - lyophilisate for use in drinking water - live viral vaccine - chickens

United Kingdom - English - VMD (Veterinary Medicines Directorate)

laboratorios hipra sa - infectious bursal disease virus - lyophilisate and solvent for suspension for injection - live viral vaccine - chickens

European Union - English - EMA (European Medicines Agency)

intervet international b.v. - live attenuated canine distemper virus strain onderstepoort: 105.1 – 106.5 tcid50, live recombinant canine parvovirus strain 630a: 105.1 – 106.7 tcid50 - immunologicals for canidae - dogs (small) - for the active immunisation of puppies from 4 weeks of age onwards to prevent clinical signs and mortality of canine distemper virus infection and canine parvovirus infection and to prevent viral excretion following canine distemper virus infection and following canine parvovirus infection.

United Kingdom - English - VMD (Veterinary Medicines Directorate)

laboratorios hipra sa - infectious bursal disease virus - lyophilisate for oral suspension - live viral vaccine - chickens