United States - English - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - indacaterol maleate (unii: 2jec1itx7r) (indacaterol - unii:8or09251mq), glycopyrrolate (unii: v92so9wp2i) (glycopyrronium - unii:a14fb57v1d) - indacaterol 27.5 ug - utibrontm neohaler® is a combination of indacaterol and glycopyrrolate indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and/or emphysema. important limitations of use: utibron neohaler is not indicated for the relief of acute bronchospasm or for the treatment of asthma [see warnings and precautions (5.1, 5.2)] . all labas are contraindicated in patients with asthma without use of a long-term asthma control medication [see warnings and precautions (5.1)] . utibron neohaler is not indicated for the treatment of asthma. utibron neohaler is contraindicated in patients who have demonstrated hypersensitivity to indacaterol, glycopyrrolate, or to any of the ingredients [see warnings and precautions (5.5)] . teratogenic effects: pregnancy category c there are no adequate and well-controlled studies with utibron neohaler or its individual components, indacaterol and glycopyrrolate, in pregnant women

United States - English - NLM (National Library of Medicine)

sunovion pharmaceuticals inc. - indacaterol maleate (unii: 2jec1itx7r) (indacaterol - unii:8or09251mq), glycopyrrolate (unii: v92so9wp2i) (glycopyrronium - unii:a14fb57v1d) - indacaterol 27.5 ug - utibron® neohaler® is a combination of indacaterol and glycopyrrolate indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and/or emphysema. important limitations of use: utibron neohaler is not indicated for the relief of acute bronchospasm or for the treatment of asthma [see warnings and precautions (5.1, 5.2)] . the safety and effectiveness of utibron in asthma have not been established. use of a laba, including utibron neohaler, without an inhaled corticosteroid is contraindicated in patients with asthma [see warnings and precautions (5.1)] . utibron neohaler is not indicated for the treatment of asthma. utibron neohaler is contraindicated in patients who have demonstrated hypersensitivity to indacaterol, glycopyrrolate, or to any of the ingredients [see warnings and precautions (5.5)] . teratogenic effects: pregnancy category c there are no adequate and well-controlled studies with utibron

United States - English - NLM (National Library of Medicine)

sunovion pharmaceuticals inc. - indacaterol maleate (unii: 2jec1itx7r) (indacaterol - unii:8or09251mq) - indacaterol 75 ug - arcapta neohaler is a long-acting beta2 -agonist indicated for long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and/or emphysema. arcapta neohaler is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see warnings and precautions (5.2) ]. arcapta neohaler is not indicated to treat asthma. the safety and effectiveness of arcapta neohaler in asthma have not been established. use of a laba, including arcapta neohaler, without an inhaled corticosteroid is contraindicated in patients with asthma [see warnings and precautions (5.1) ]. arcapta neohaler is not indicated for the treatment of asthma. arcapta neohaler is contraindicated in patients with a history of hypersensitivity to indacaterol or to any of the ingredients [see warnings and precautions (5.4)]. teratogenic effects: pregnancy category c. there are no adequate and well-controlled studies with arc

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).

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); 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.

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

United States - English - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - indacaterol maleate (unii: 2jec1itx7r) (indacaterol - unii:8or09251mq) - indacaterol 75 ug

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)