Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

glenmark pharmaceuticals (malaysia) sdn. bhd. - budesonide; formoterol fumarate -

Israel - English - Ministry of Health

astrazeneca (israel) ltd - budesonide; formoterol fumarate dihydrate; glycopyrronium - suspension for inhalation - formoterol fumarate dihydrate 5 mcg; glycopyrronium 7.2 mcg; budesonide 160 mcg - budesonide - 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

Ireland - English - HPRA (Health Products Regulatory Authority)

rowex ltd - budesonide; formoterol fumarate dihydrate - inhalation powder, pre-dispensed - 320/9 microgram(s) - formoterol and budesonide

Malta - English - Medicines Authority

chiesi farmaceutici s.p.a via palermo 26/a, 43122 parma, italy - beclometasone dipropionate, formoterol fumarate, dihydrate - pressurised inhalation, solution - beclometasone dipropionate 100 µg formoterol fumarate dihydrate 6 µg - drugs for obstructive airway diseases

Ireland - English - HPRA (Health Products Regulatory Authority)

merit pharmaceuticals limited - budesonide; formoterol fumarate dihydrate - inhalation powder - 200 µg/6 µg/inhalation - formoterol and budesonide

Ireland - English - HPRA (Health Products Regulatory Authority)

merit pharmaceuticals limited - budesonide dihydrate; formoterol fumarate dihydrate - inhalation powder - 400/12 µg/µg - formoterol and budesonide

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.

Ireland - English - HPRA (Health Products Regulatory Authority)

orion corporation - budesonide; formoterol fumarate dihydrate - inhalation powder - 160/4.5 microgram(s) - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and budesonide

Ireland - English - HPRA (Health Products Regulatory Authority)

orion corporation - budesonide; formoterol fumarate dihydrate - inhalation powder - 320/9 microgram(s) - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and budesonide

Ireland - English - HPRA (Health Products Regulatory Authority)

imed healthcare ltd. - formoterol fumarate dihydrate; budesonide - inhalation powder - 400 µg /12 µg/inhalation - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and budesonide - adrenergics and other drugs for obstructive airway diseases. - it is indicated: in adults and adolescents aged 12 to 17 years for the regular treatment of asthma where use of a combination is appropriate; in adults, aged 18 years and older, for the symptomatic treatment of patients with severe copd and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators