Regno Unito - inglese - MHRA (Medicines & Healthcare Products Regulatory Agency)

novartis pharmaceuticals uk ltd - glycopyrronium bromide - inhalation powder - 55microgram

Malesia - inglese - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

novartis corporation (malaysia) sdn. bhd. - glycopyrronium bromide -

Malesia - inglese - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

novartis corporation (malaysia) sdn. bhd. - glycopyrronium bromide -

Unione Europea - inglese - EMA (European Medicines Agency)

astrazeneca ab - budesonide, formoterol fumarate dihydrate, glycopyrronium bromide - pulmonary disease, chronic obstructive - drugs for obstructive airway diseases, - riltrava 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 (for effects on symptoms control and prevention of exacerbations see section 5.1).

Israele - inglese - Ministry of Health

kamada ltd, israel - beclometasone dipropionate; formoterol fumarate dihydrate; glycopyrronium as bromide - pressurised solution - glycopyrronium as bromide 9 mcg/delivered dose; formoterol fumarate dihydrate 5.2 mcg/delivered dose; beclometasone dipropionate 87.4 mcg/delivered dose - formoterol, glycopyrronium bromide and beclometasone - copd 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 a combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist. asthma maintenance 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.…

Australia - inglese - 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 - inglese - 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).

Zimbabwe - inglese - Medicines Control Authority

norvatis pharma ag - glycopyrronium bromide; indacaterol (as maleate) - capsule - 110; 50mcg

Arabia Saudita - inglese - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

novartis, switzerland - glycopyrronium bromide,(indacaterol (as acetate - capsule - 50,110 µg,

Giappone - inglese - すりの適正使用協議会 RAD-AR Council, Japan

novartis pharma k.k. - glycopyrronium bromide; indacaterol maleate - yellow transparent/colorless and transparent inhalation capsule, major axis: 15.8 mm, minor axis: 5.6 mm