Malta - engelsk - Malta Medicines Authority

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

Malta - engelsk - Malta Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - salmeterol xinafoate, fluticasone propionate - pressurised inhalation, suspension - salmeterol xinafoate 25 µg fluticasone propionate 125 µg - drugs for obstructive airway diseases

Malta - engelsk - Malta Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - salmeterol xinafoate, fluticasone propionate - pressurised inhalation, suspension - salmeterol xinafoate 25 µg fluticasone propionate 250 µg - drugs for obstructive airway diseases

Den europeiske union - engelsk - EMA (European Medicines Agency)

astrazeneca ab - formoterol fumarate dihydrate, glycopyrronium bromide, budesonide - pulmonary disease, chronic obstructive - drugs for obstructive airway diseases, - trixeo aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (copd) who are not adequately treated by a combination of an inhaled corticosteroid and a long acting beta2 agonist or combination of a long-acting beta2 agonist and a long acting muscarinic antagonist.

Malta - engelsk - Malta Medicines Authority

neofarma pharmaceuticals limited 42-46, mill street, qormi, qrm 3105, malta - salmeterol xinafoate, fluticasone propionate - inhalation powder - salmeterol xinafoate 50 µg fluticasone propionate 100 µg - drugs for obstructive airway diseases

Den europeiske union - engelsk - EMA (European Medicines Agency)

astrazeneca ab - budesonide, formoterol fumarate dihydrate, glycopyrronium bromide - pulmonary disease, chronic obstructive - drugs for obstructive airway diseases, - riltrava aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (copd) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2 agonist or combination of a long-acting beta2 agonist and a long-acting muscarinic antagonist (for effects on symptoms control and prevention of exacerbations see section 5.1).

Irland - engelsk - HPRA (Health Products Regulatory Authority)

fannin (uk) ltd - salmeterol - pressurised inhalation, suspension - 25 microgram(s) - selective beta-2-adrenoreceptor agonists; salmeterol

Den europeiske union - engelsk - EMA (European Medicines Agency)

novartis europharm limited - indacaterol, glycopyrronium bromide - pulmonary disease, chronic obstructive - adrenergics in combinations with anticholinergics incl. triple combinations with corticosteroids, drugs for obstructive airway diseases, - ultibro breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (copd).

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

glaxosmithkline australia pty ltd - fluticasone propionate, quantity: 250 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 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.

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

glaxosmithkline australia pty ltd - fluticasone propionate, quantity: 125 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 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.