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)

astrazeneca pty ltd - budesonide, quantity: 160 microgram/actuation; formoterol fumarate dihydrate, quantity: 5 microgram/actuation; glycopyrronium bromide, quantity: 9 microgram/actuation (equivalent: glycopyrronium, qty 7.2 microgram/actuation) - inhalation, pressurised - excipient ingredients: calcium chloride dihydrate; distearoylphosphatidylcholine; norflurane - maintenance treatment to prevent exacerbations and relieve symptoms in adults with moderate, severe, or very severe chronic obstructive pulmonary disease (copd) who require treatment with a combination of an inhaled corticosteroid (ics), a long-acting beta2-agonist (laba), and a long-acting muscarinic antagonist (lama). breztri aerosphere 160/7.2/5 is not indicated for the initiation of therapy in copd.

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

astrazeneca pty ltd - budesonide, quantity: 160 microgram/actuation; formoterol fumarate dihydrate, quantity: 5 microgram/actuation; glycopyrronium bromide, quantity: 9 microgram/actuation (equivalent: glycopyrronium, qty 7.2 microgram/actuation) - inhalation, pressurised - excipient ingredients: calcium chloride dihydrate; distearoylphosphatidylcholine; norflurane - maintenance treatment to prevent exacerbations and relieve symptoms in adults with moderate, severe, or very severe chronic obstructive pulmonary disease (copd) who require treatment with a combination of an inhaled corticosteroid (ics), a long-acting beta2-agonist (laba), and a long-acting muscarinic antagonist (lama). breztri aerosphere 160/7.2/5 is not indicated for the initiation of therapy in copd.

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.

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.…

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.

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

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

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).

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

astrazeneca pty ltd - formoterol fumarate dihydrate, quantity: 5 microgram/actuation; glycopyrronium bromide, quantity: 9 microgram/actuation (equivalent: glycopyrronium, qty 7.2 microgram/actuation) - inhalation, pressurised - excipient ingredients: calcium chloride dihydrate; distearoylphosphatidylcholine; norflurane - bevespi aerosphere is indicated as a long-term twice-daily maintenance bronchodilator treatment to relieve symptoms in patients with chronic obstructive pulmonary disease (copd).

European Union - English - 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).