Zimbabwe - anglais - Medicines Control Authority

norvatis pharma ag - glycopyrronium bromide; indacaterol (as maleate) - capsule - 110; 50mcg

Philippines - anglais - FDA (Food And Drug Administration)

n/a; importer: novartis healthcare philippines, inc.; distributor: novartis healthcare philippines, inc. - indacaterol (as acetate) , glycopyrronium (as bromide) , mometasone furoate - powder for inhalation in hard capsule - 150 mcg/ 50 mcg/ 80 mcg

Philippines - anglais - FDA (Food And Drug Administration)

n/a; importer: novartis healthcare philippines, inc.; distributor: novartis healthcare philippines, inc. - indacaterol (as acetate) , glycopyrronium (as bromide) , mometasone furoate - powder for inhalation in hard capsule - 150 mcg/50mcg/160mcg

Philippines - anglais - FDA (Food And Drug Administration)

switzerland; importer: n/a; distributor: novartis healthcare philippines, inc. - indacaterol (as acetate) , glycopyrronium (as bromide) , mometasone furoate - powder for inhalation in hard capsule - 150 mcg/ 50 mcg/ 160 mcg

Australie - anglais - Department of Health (Therapeutic Goods Administration)

grand medical pty ltd - indacaterol acetate, quantity: 173 microgram (equivalent: indacaterol, qty 150 microgram); mometasone furoate, quantity: 160 microgram; glycopyrronium bromide, quantity: 63 microgram (equivalent: glycopyrronium, qty 50 microgram) - capsule, hard - excipient ingredients: lactose monohydrate; magnesium stearate - zimbus breezhaler is indicated as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long-acting beta2-agonist and an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

grand medical pty ltd - glycopyrronium bromide, quantity: 63 microgram (equivalent: glycopyrronium, qty 50 microgram); mometasone furoate, quantity: 80 microgram; indacaterol acetate, quantity: 173 microgram (equivalent: indacaterol, qty 150 microgram) - capsule, hard - excipient ingredients: lactose monohydrate; magnesium stearate - zimbus breezhaler is indicated as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long-acting beta2-agonist and an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year.

Union européenne - anglais - myHealthbox

novartis europharm limited - indacaterol, glycopyrronium - inhalation powder, hard capsule - 85 micrograms/43 micrograms - pulmonary disease, chronic obstructive - drugs for obstructive airway diseases, adrenergics in combination with anticholinergics - indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (copd)

Malaisie - anglais - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

novartis corporation (malaysia) sdn. bhd. - glycopyrronium bromide; mometasone furoate; indacaterol acetate -

Australie - anglais - 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.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - indacaterol acetate, quantity: 173 microgram (equivalent: indacaterol, qty 150 microgram); mometasone furoate, quantity: 320 microgram - capsule, hard - excipient ingredients: lactose monohydrate - atectura breezhaler is indicated as a once-daily maintenance treatment of asthma in adults and adolescents 12 years of age and older where use of a combination of long-acting beta2-agonist and inhaled corticosteroid is appropriate:,- patients not adequately controlled with inhaled corticosteroids and "as needed" inhaled short-acting beta2-agonists or,- patients not adequately controlled with long-acting beta2-agonists and low dose of inhaled corticosteroids and "as needed" inhaled short-acting beta2-agonists