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.

European Union - English - myHealthbox

novartis europharm limited - indacaterol, glycopyrronium bromide - inhalation powder, hard capsule - 110 microgram indacaterol and 50 microgram glycopyrronium - 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)

European Union - English - 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)

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: 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

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.

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

recordati rare diseases australia pty ltd - pasireotide diaspartate, quantity: 376.2 microgram (equivalent: pasireotide, qty microgram) - injection, solution - excipient ingredients: water for injections; mannitol; tartaric acid; sodium hydroxide - the treatment of adult patients with cushing?s disease for whom surgery is not an option or for whom surgery has failed.

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

novartis pharmaceuticals australia pty ltd - indacaterol maleate, quantity: 389 microgram (equivalent: indacaterol, qty 300 microgram) - capsule, hard - excipient ingredients: gelatin; lactose monohydrate; titanium dioxide; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; brilliant blue fcf aluminium lake; industrial methylated spirit; iron oxide black; ethanol; shellac; strong ammonia solution; sulfuric acid - onbrez breezhaler is a long-acting beta2-agonist indicated for long-term, once-daily, maintenance bronchodilator treatment of airflow limitation in patients with chronic obstructive pulmonary disease (copd).

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

novartis pharmaceuticals australia pty ltd - indacaterol maleate, quantity: 194 microgram (equivalent: indacaterol, qty 150 microgram) - capsule, hard - excipient ingredients: gelatin; lactose monohydrate; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; shellac; sulfuric acid - onbrez breezhaler is a long-acting beta2-agonist indicated for long-term, once-daily, maintenance bronchodilator treatment of airflow limitation in patients with chronic obstructive pulmonary disease (copd).

Ireland - English - HPRA (Health Products Regulatory Authority)

cipla europe nv - fluticasone propionate; salmeterol xinafoate - pressurised inhalation, suspension - 25/125 microgram(s) - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; salmeterol and fluticasone