Australija - anglų - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - fluticasone propionate, quantity: 250 microgram/actuation; salmeterol xinafoate, quantity: 72.5 microgram/actuation (equivalent: salmeterol, qty 50 microgram/actuation) - inhalation, powder for - excipient ingredients: lactose monohydrate - for the regular treatment of asthma, where the use of a combination product is appropriate. this may include: patients on effective maintenance doses of long-acting beta2-agonists and inhaled corticosteroids. patients who are symptomatic on current inhaled corticosteroid therapy. initiation of maintenance therapy in those patients with moderate persistent asthma not adequately controlled on as needed reliever medication, and who have moderate/severe airway limitation and daily symptoms requiring reliever medication every day (see clinical trials). for the symptomatic treatment of patients with severe copd (fev1<50% predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular beta-2 agonist bronchodilator therapy. seretide is not indicated for the initiation of bronchodilator therapy in copd.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - salmeterol xinafoate, quantity: 72.5 microgram/actuation (equivalent: salmeterol, qty 50 microgram/actuation); fluticasone propionate, quantity: 100 microgram/actuation - inhalation, powder for - excipient ingredients: lactose monohydrate - for the regular treatment of asthma, where the use of a combination product is appropriate. this may include: patients on effective maintenance doses of long-acting beta2-agonists and inhaled corticosteroids. patients who are symptomatic on current inhaled corticosteroid therapy. initiation of maintenance therapy in those patients with moderate persistent asthma not adequately controlled on as needed reliever medication, and who have moderate/severe airway limitation and daily symptoms requiring reliever medication every day (see clinical trials). for the symptomatic treatment of patients with severe copd (fev1<50% predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular beta-2 agonist bronchodilator therapy. seretide is not indicated for the initiation of bronchodilator therapy in copd.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - fluticasone propionate, quantity: 250 microgram/actuation - inhalation, pressurised - excipient ingredients: norflurane - for use in the prophylactic management of asthma in adults and children over 4 years of age.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - fluticasone propionate, quantity: 125 microgram/actuation - inhalation, pressurised - excipient ingredients: norflurane - for use in the prophylactic management of asthma in adults and children over 4 years of age.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - atovaquone, quantity: 250 mg; proguanil hydrochloride, quantity: 100 mg - tablet, film coated - excipient ingredients: poloxamer; hyprolose; hypromellose; macrogol 400; magnesium stearate; microcrystalline cellulose; sodium starch glycollate; titanium dioxide; macrogol 8000; iron oxide red; povidone - malarone is indicated for the treatment of plasmodium falciparum malaria in adults and children aged 3 years or older. indications as at 1 november 2001: "prophylaxis of plasmodium falciparum malaria in individuals weighing >40kg". this approval is based on the evaluation of the information and data provided with the original letter of application and with any subsequent correspondence and submissions relating to the application. indications as at 13 january 2003: prophylaxis of plasmodium falciparum malaria in adults and children 11kg and over; treatment of plasmodium falciparum malaria in adults and children aged 3 years or older.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - mepolizumab, quantity: 100 mg - injection, solution - excipient ingredients: sucrose; dibasic sodium phosphate heptahydrate; citric acid monohydrate; polysorbate 80; disodium edetate; water for injections - severe eosinophilic asthma,nucala is indicated as an add-on treatment for severe eosinophilic asthma in patients aged 12 years and over (see section 5.1 pharmacodynamic properties, clinical trials).,chronic rhinosinusitis with nasal polyps (crswnp),nucala is indicated as add-on treatment in adult patients (18 years and above) with severe chronic rhinosinusitis with nasal polyps (crswnp) with an inadequate response to intranasal corticosteroids (see section 5.1 pharmacodynamic properties, clinical 2 trials).,relapsed or refractory egpa,nucala is indicated as an add-on treatment for relapsing or refractory eosinophilic granulomatosis with polyangiitis (egpa) in adult patients aged 18 years and over (see section 5.1 pharmacodynamic properties, clinical trials).

Australija - anglų - 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).

Australija - anglų - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - mepolizumab, quantity: 100 mg - injection, powder for - excipient ingredients: polysorbate 80; water for injections; dibasic sodium phosphate heptahydrate; sucrose - severe eosinophilic asthma,nucala is indicated as an add-on treatment for severe eosinophilic asthma in patients aged 12 years and over (see section 5.1 pharmacodynamic properties, clinical trials).,chronic rhinosinusitis with nasal polyps (crswnp),nucala is indicated as add-on treatment in adult patients (18 years and above) with severe chronic rhinosinusitis with nasal polyps (crswnp) with an inadequate response to intranasal corticosteroids (see section 5.1 pharmacodynamic properties, clinical 2 trials).,relapsed or refractory egpa,nucala is indicated as an add-on treatment for relapsing or refractory eosinophilic granulomatosis with polyangiitis (egpa) in adult patients aged 18 years and over (see section 5.1 pharmacodynamic properties, clinical trials).

Australija - anglų - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - fluticasone furoate, quantity: 200 microgram - inhalation, powder for - excipient ingredients: lactose monohydrate - arnuity ellipta is indicated for the maintenance treatment of asthma in patients aged 5 years and over.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - fluticasone furoate, quantity: 100 microgram - inhalation, powder for - excipient ingredients: lactose monohydrate - arnuity ellipta is indicated for the maintenance treatment of asthma in patients aged 5 years and over.