Malta - English - Malta Medicines Authority

orion corporation orionintie 1, fi-02200 espoo, finland - formoterol fumarate, dihydrate, budesonide - inhalation powder - formoterol fumarate dihydrate 9 µg budesonide 320 µg - drugs for obstructive airway diseases

Malta - English - Malta Medicines Authority

orion corporation orionintie 1, fi-02200 espoo, finland - formoterol fumarate, dihydrate, budesonide - inhalation powder - formoterol fumarate dihydrate 4.5 µg budesonide 160 µg - drugs for obstructive airway diseases

Malta - English - Malta Medicines Authority

orion corporation orionintie 1, fi-02200 espoo, finland - formoterol fumarate, dihydrate, budesonide - inhalation powder - formoterol fumarate dihydrate 9 µg budesonide 320 µg - drugs for obstructive airway diseases

Israel - English - Ministry of Health

kamada ltd, israel - beclometasone dipropionate anhydrous; formoterol fumarate dihydrate - pressurised solution - formoterol fumarate dihydrate 6 mcg/dose; beclometasone dipropionate anhydrous 100 mcg/dose - formoterol and beclometasone - beclometasone - foster is indicated in the regular treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting beta2-agonist) is appropriate:- patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled rapid-acting beta2-agonist or- patients already adequately controlled on both inhaled corticosteroids and long-acting beta2-agonists.copd :symptomatic treatment of patients with severe copd (fev1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.

Malta - English - Malta Medicines Authority

novartis ireland limited vista building, elm park, merrion road, ballsbridge, dublin 4,, ireland - formoterol - inhalation powder hard capsule - formoterol 12 µg - drugs for obstructive airway diseases

Israel - English - Ministry of Health

kamada ltd, israel - beclometasone dipropionate anhydrous; formoterol fumarate dihydrate - pressurised solution - formoterol fumarate dihydrate 6 mcg/actuation; beclometasone dipropionate anhydrous 200 mcg/actuation - formoterol and beclometasone - foster 200/6 is indicated in the regular treatment of asthma in adults where use of a combination product (inhaled corticosteroid and long-acting beta2-agonist) is appropriate:- patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled rapid-acting beta2-agonist or- patients already adequately controlled on both inhaled corticosteroids and long-acting beta2-agonists.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - formoterol fumarate 0.42%{relative} ((micronised)) - powder for inhalation - 12 mcg - active: formoterol fumarate 0.42%{relative} ((micronised)) excipient: lactose monohydrate

European Union - English - 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - formoterol fumarate 12ug;   - powder for inhalation - 12 mcg/dose - active: formoterol fumarate 12ug   excipient: lactose monohydrate

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - formoterol fumarate 4.5ug (/dose for the m3 device. equivalent to 6 µg/dose of the m2 device.);   - powder for inhalation - 6 mcg/dose - active: formoterol fumarate 4.5ug (/dose for the m3 device. equivalent to 6 µg/dose of the m2 device.)   excipient: lactose monohydrate - oxis turbuhaler is indicated as add on therapy to maintenance treatment with inhaled corticosteroids for the treatment of broncho-obstructive symptoms and prevention of exercise-induced symptoms in adults and children six years of age and over with asthma when adequate treatment with corticosteroids is not sufficient. oxis turbuhaler should not be used in the treatment of acute asthmatic symptoms or in patients whose asthma can be managed by occasional use of short-acting beta-2 agonists.