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

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

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

Ireland - English - HPRA (Health Products Regulatory Authority)

chiesi farmaceutici s.p.a. - beclometasone dipropionate; formoterol fumarate dihydrate - inhalation powder - 200 micrograms/ 12 microgram(s) - 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

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

chiesi ltd - beclometasone dipropionate; formoterol fumarate dihydrate - pressurised inhalation - 200microgram ; 6microgram

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

orient europharma (m) sdn bhd - beclometasone dipropionate; formoterol fumarate dihydrate -

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.…

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).