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

novartis pharmaceuticals australia pty ltd - glycopyrronium bromide, quantity: 63 microgram (equivalent: glycopyrronium, qty 50 microgram); indacaterol maleate, quantity: 143 microgram (equivalent: indacaterol, qty 110 microgram) - inhalation, powder for - excipient ingredients: lactose monohydrate; magnesium stearate - ultibro breezhaler 110/50 is indicated as a once-daily maintenance bronchodilator treatment to relieve symptoms in patients with chronic obstructive pulmonary disease (copd), and for the reduction of exacerbations of copd in patients with a history of exacerbations.

Israel - English - Ministry of Health

novartis israel ltd - glycopyrronium as bromide; indacaterol as maleate - inhalation powder hard capsules - indacaterol as maleate 110 mcg; glycopyrronium as bromide 50 mcg - indacaterol - ultibro breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (copd).

Israel - English - Ministry of Health

novartis israel ltd - glycopyrronium as bromide; indacaterol as acetate; mometasone furoate - hard capsule - mometasone furoate 160 mcg; glycopyrronium as bromide 50 mcg; indacaterol as acetate 150 mcg - mometasone - enerzair 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.important limitations of use:enerzair breezhaler is not indicated in patients with copd.

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

novartis pharmaceuticals australia 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 - enerzair 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.

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

novartis pharmaceuticals australia 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 - enerzair 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - glycopyrronium bromide 63ug equivalent to glycopyrronium 50 mcg;  ; indacaterol maleate 143ug equivalent to indacaterol 110 mcg;   - powder filled inhalation capsule - 110/50mcg - active: glycopyrronium bromide 63ug equivalent to glycopyrronium 50 mcg   indacaterol maleate 143ug equivalent to indacaterol 110 mcg   excipient: carrageenan hypromellose lactose monohydrate magnesium stearate potassium chloride purified water tartrazine - ultibro breezhaler 110/50 is indicated as a once-daily maintenance bronchodilator treatment to relieve symptoms in patients with chronic obstructive pulmonary disease (copd), and for the reduction of exacerbations of copd in patients with a history of exacerbations.

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

novartis pharmaceuticals australia pty ltd - glycopyrronium bromide, quantity: 63 microgram (equivalent: glycopyrronium, qty 50 microgram) - inhalation, powder for - excipient ingredients: hypromellose; carrageenan; potassium chloride; magnesium stearate; purified water; sunset yellow fcf; lactose monohydrate; strong ammonia solution; ethanol absolute; propylene glycol; potassium hydroxide; butan-1-ol; shellac; iron oxide black; isopropyl alcohol - seebri breezhaler is indicated as a once-daily maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (copd).

Canada - English - Health Canada

novartis pharmaceuticals canada inc - glycopyrronium (glycopyrronium bromide); indacaterol (indacaterol maleate) - capsule - 50mcg; 110mcg - glycopyrronium (glycopyrronium bromide) 50mcg; indacaterol (indacaterol maleate) 110mcg - antimuscarinics antispasmodics

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

novartis pharma stein ag - indacaterol (indacaterol maleate), glycopyrronium (glycopyrronium bromide) - powder for inhalation, hard capsules - 110mcg+50mcg

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: novartis healthcare philippines, inc.; distributor: unilab, inc. - indacaterol (as maleate) , glycopyrronium (as bromide) - pre-metered dose dry powder for inhalation - 110 mcg/ 50 mcg (equivalent to 85 mcg/43 mcg delivered dose)