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

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

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. 

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.…

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).

Ireland - English - HPRA (Health Products Regulatory Authority)

chiesi farmaceutici s.p.a. - beclometasone dipropionate; formoterol fumarate dihydrate - pressurised inhalation, solution - 100 /6 µg/µg - formoterol and beclometasone

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

Philippines - English - FDA (Food And Drug Administration)

oep philippines, inc.; distributor: zuellig pharma corp. - beclometasone dipropionate , formoterol fumarate dihydrate , glycopyrronium bromide - 100 mcg/6 mcg/12.5 mcg per actuation metered dose inhaler - 100 mcg + 6 mcg + 10 mcg

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.

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 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.