Canada - English - Health Canada

novartis pharmaceuticals canada inc - indacaterol (indacaterol acetate); mometasone furoate - capsule - 150mcg; 160mcg - indacaterol (indacaterol acetate) 150mcg; mometasone furoate 160mcg - adrenals

Canada - English - Health Canada

novartis pharmaceuticals canada inc - indacaterol (indacaterol maleate) - capsule - 75mcg - indacaterol (indacaterol maleate) 75mcg - selective beta 2-adrenergic agonists

Canada - English - Health Canada

novartis pharmaceuticals canada inc - indacaterol (indacaterol acetate); glycopyrronium (glycopyrronium bromide); mometasone furoate - capsule - 150mcg; 50mcg; 160mcg - indacaterol (indacaterol acetate) 150mcg; glycopyrronium (glycopyrronium bromide) 50mcg; mometasone furoate 160mcg - antimuscarinics antispasmodics

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 - 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.

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

siegfried barbera s.l. - indacaterol (indacaterol acetate), glycopyrronium bromide, mometasone fuora - powder for inhalation, capsules hard - 150mcg+ 50mcg+ 160mcg

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)

European Union - English - EMA (European Medicines Agency)

novartis europharm limited - glycopyrronium bromide, indacaterol maleate - pulmonary disease, chronic obstructive - drugs for obstructive airway diseases, - ulunar breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (copd).

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

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

European Union - English - EMA (European Medicines Agency)

novartis europharm limited  - indacaterol acetate, mometasone furoate - asthma - drugs for obstructive airway diseases, - atectura breezhaler is indicated as a maintenance treatment of asthma in adults and adolescents 12 years of age and older not adequately controlled with inhaled corticosteroids and inhaled short acting beta2-agonists.