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

chiesi australia pty ltd - formoterol fumarate dihydrate, quantity: 6 microgram; beclometasone dipropionate, quantity: 200 microgram; glycopyrronium bromide, quantity: 12.5 microgram (equivalent: glycopyrronium, qty microgram) - inhalation, pressurised - excipient ingredients: ethanol absolute; norflurane; dilute hydrochloric acid - asthma trimbow 200/6/10 maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and high dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.

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

chiesi australia pty ltd - formoterol fumarate dihydrate, quantity: 6 microgram; beclometasone dipropionate, quantity: 100 microgram; glycopyrronium bromide, quantity: 12.5 microgram (equivalent: glycopyrronium, qty 10 microgram) - inhalation, pressurised - excipient ingredients: ethanol absolute; norflurane; hydrochloric acid - copd trimbow 100/6/10 is indicated for 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 (ics) and a long-acting beta2-agonist (laba) or a combination of a laba and a long-acting muscarinic antagonist (lama). asthma trimbow 100/6/10 maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and medium dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.

Israel - English - Ministry of Health

kamada ltd, israel - beclometasone dipropionate; formoterol fumarate dihydrate; glycopyrronium as bromide - pressurised solution - glycopyrronium as bromide 9 mcg/delivered dose; formoterol fumarate dihydrate 5.2 mcg/delivered dose; beclometasone dipropionate 87.4 mcg/delivered dose - formoterol, glycopyrronium bromide and beclometasone - copd 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 a combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist. asthma maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and medium dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.…

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

orient europharma (m) sdn bhd - beclomethasone dipropionate; formoterol fumarate dihydrate; glycopyrronium bromide -

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

chiesi ltd - beclometasone dipropionate; glycopyrronium bromide; formoterol fumarate dihydrate - pressurised inhalation - 87microgram/1dose ; 9microgram/1dose ; 5microgram/1dose

European Union - English - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a. - formoterol fumarate dihydrate, glycopyrronium, beclometasone dipropionate - pulmonary disease, chronic obstructive - drugs for obstructive airway diseases, - 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 (for effects on symptoms control and prevention of exacerbations see section 5.1).

European Union - English - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a. - beclometasone dipropionate, formoterol fumarate dihydrate, glycopyrronium bromide - pulmonary disease, chronic obstructive - drugs for obstructive airway diseases, - maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and high dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.copdmaintenance 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 a 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).asthmamaintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and medium dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year. 

European Union - English - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a. - beclometasone dipropionate, formoterol fumarate dihydrate, glycopyrronium - pulmonary disease, chronic obstructive - drugs for obstructive airway diseases, - 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 (for effects on symptoms control and prevention of exacerbations see section 5.1).

Canada - English - Health Canada

astrazeneca canada inc - formoterol fumarate dihydrate; glycopyrronium (glycopyrronium bromide) - aerosol, metered dose - 5.8mcg; 8.3mcg - formoterol fumarate dihydrate 5.8mcg; glycopyrronium (glycopyrronium bromide) 8.3mcg - antimuscarinics antispasmodics

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

a menarini australia pty ltd - aclidinium bromide, quantity: 0.4 mg/actuation; formoterol fumarate dihydrate, quantity: 0.012 mg/actuation - inhalation, powder for - excipient ingredients: lactose monohydrate - brimica genuair 340/12 is indicated as a long-term twice daily maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (copd).