Den europeiske union - engelsk - EMA (European Medicines Agency)

astrazeneca ab - glycopyrronium, formoterol fumarate dihydrate - pulmonary disease, chronic obstructive - formoterol and glycopyrronium bromide - bevespi aerosphere is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (copd).

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

novartis corporation (malaysia) sdn. bhd. - indacaterol maleate; glycopyrronium bromide -

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

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

Israel - engelsk - 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.

Den europeiske union - engelsk - EMA (European Medicines Agency)

astrazeneca ab - formoterol fumarate dihydrate, glycopyrronium bromide, budesonide - pulmonary disease, chronic obstructive - drugs for obstructive airway diseases, - trixeo aerosphere is indicated as a 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 combination of a long-acting beta2 agonist and a long acting muscarinic antagonist.

USA - engelsk - 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

Den europeiske union - engelsk - 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. 

USA - engelsk - 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

Singapore - engelsk - HSA (Health Sciences Authority)

novartis (singapore) pte ltd - glycopyrronium bromide equivalent to glycopyrronium; indacaterol acetate equivalent to indacaterol; mometasone furoate - powder, metered - glycopyrronium bromide equivalent to glycopyrronium 50 mcg; indacaterol acetate equivalent to indacaterol 150 mcg; mometasone furoate 160 mcg

Singapore - engelsk - HSA (Health Sciences Authority)

novartis (singapore) pte ltd - glycopyrronium bromide 63mcg eqv glycopyrronium - capsule - 50 mcg - glycopyrronium bromide 63mcg eqv glycopyrronium 50 mcg