Australien - engelsk - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - fluticasone propionate, quantity: 50 microgram/actuation; salmeterol xinafoate, quantity: 36.3 microgram/actuation (equivalent: salmeterol, qty 25 microgram/actuation) - inhalation, pressurised - excipient ingredients: norflurane - 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 beta-2-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 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.

Irland - engelsk - HPRA (Health Products Regulatory Authority)

pco manufacturing ltd. - salmeterol; fluticasone propionate - inhalation powder, pre-dispensed - 50/250 microgram(s) - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; salmeterol and fluticasone

Malta - engelsk - Medicines Authority

glaxo smithkline ireland limited 12, riverwalk, citywest business campus, dublin 24, ireland - fluticasone propionate - pressurised inhalation, suspension - fluticasone propionate 250 µg - drugs for obstructive airway diseases

Malta - engelsk - Medicines Authority

glaxo smithkline ireland limited 12, riverwalk, citywest business campus, dublin 24, ireland - fluticasone propionate, salmeterol - inhalation powder - fluticasone propionate 250 µg salmeterol 50 µg - drugs for obstructive airway diseases

Irland - engelsk - HPRA (Health Products Regulatory Authority)

haleon ireland limited - fluticasone propionate (micronised) - nasal spray, suspension - 50 mcg/acutuation - corticosteroids; fluticasone

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - salmeterol xinafoate, quantity: 0.0725 mg; fluticasone propionate, quantity: 0.25 mg - 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 beta 2 agonists and inhaled corticosteroids ? patients who are symptomatic on current inhaled corticosteroid therapy for the symptomatic treatment of patients with severe copd (fev1 not more than 50 per cent predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular beta 2 agonist bronchodilator therapy. seroflo multihaler 250/50 is not indicated for the initiation of bronchodilator therapy in copd.

USA - engelsk - NLM (National Library of Medicine)

prasco laboratories - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u), salmeterol xinafoate (unii: 6ew8q962a5) (salmeterol - unii:2i4bc502bt) - fluticasone propionate and salmeterol hfa is indicated for treatment of asthma in adult and adolescent patients aged 12 years and older. fluticasone propionate and salmeterol hfa should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ics) or whose disease warrants initiation of treatment with both an ics and long-acting beta2 -adrenergic agonist (laba). limitations of use fluticasone propionate and salmeterol hfa is not indicated for the relief of acute bronchospasm. fluticasone propionate and salmeterol hfa is contraindicated in the following conditions: risk summary there are insufficient data on the use of fluticasone propionate and salmeterol hfa or individual monoproducts, fluticasone propionate and salmeterol xinafoate, in pregnant women. there are clinical considerations with the use of fluticasone propionate and salmeterol hfa in pregnant women. (see clinical considerations.) in animals, teratogenicity characteristic of cortic

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - salmeterol xinafoate, quantity: 36.3 microgram/actuation (equivalent: salmeterol, qty 25 microgram/actuation); fluticasone propionate, quantity: 125 microgram/actuation - inhalation, pressurised - excipient ingredients: norflurane - 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.,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. pavtide is not indicated for the initiation of bronchodilator therapy in copd.

Irland - engelsk - HPRA (Health Products Regulatory Authority)

fannin (uk) ltd - fluticasone propionate, salmeterol xinafoate - pressurised inhalation suspension - 25/250 microgram - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics

Canada - engelsk - Health Canada

apotex inc - fluticasone propionate - metered-dose aerosol - 250mcg - fluticasone propionate 250mcg - adrenals