Israel - English - Ministry of Health

novartis israel ltd - glycopyrronium as bromide; indacaterol as maleate - inhalation powder hard capsules - indacaterol as maleate 110 mcg; glycopyrronium as bromide 50 mcg - indacaterol - ultibro breezhaler is 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 - glycopyrronium bromide, quantity: 63 microgram (equivalent: glycopyrronium, qty 50 microgram) - inhalation, powder for - excipient ingredients: hypromellose; carrageenan; potassium chloride; magnesium stearate; purified water; sunset yellow fcf; lactose monohydrate; strong ammonia solution; ethanol absolute; propylene glycol; potassium hydroxide; butan-1-ol; shellac; iron oxide black; isopropyl alcohol - seebri breezhaler is indicated as a once-daily maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (copd).

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

novartis pharmaceuticals uk ltd - glycopyrronium bromide; indacaterol maleate - inhalation powder - 54microgram/1dose ; 85microgram/1dose

Singapore - English - HSA (Health Sciences Authority)

novartis (singapore) pte ltd - glycopyrronium bromide 63mcg eqv glycopyrronium; indacaterol maleate 143mcg eqv indacaterol (micronized) - capsule - 50 mcg - glycopyrronium bromide 63mcg eqv glycopyrronium 50 mcg; indacaterol maleate 143mcg eqv indacaterol (micronized) 110 mcg

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

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

Canada - English - Health Canada

novartis pharmaceuticals canada inc - glycopyrronium (glycopyrronium bromide); indacaterol (indacaterol maleate) - capsule - 50mcg; 110mcg - glycopyrronium (glycopyrronium bromide) 50mcg; indacaterol (indacaterol maleate) 110mcg - antimuscarinics antispasmodics

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - glycopyrronium bromide 63ug equivalent to glycopyrronium 50 mcg;  ; indacaterol maleate 143ug equivalent to indacaterol 110 mcg;   - powder filled inhalation capsule - 110/50mcg - active: glycopyrronium bromide 63ug equivalent to glycopyrronium 50 mcg   indacaterol maleate 143ug equivalent to indacaterol 110 mcg   excipient: carrageenan hypromellose lactose monohydrate magnesium stearate potassium chloride purified water tartrazine - 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - glycopyrronium bromide 0.063mg equivalent to glycopyrronium 0.05 mg;   - powder filled inhalation capsule - 50 mcg - active: glycopyrronium bromide 0.063mg equivalent to glycopyrronium 0.05 mg   excipient: lactose monohydrate magnesium stearate orange capsule (novartis) - once-daily maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (copd).

European Union - English - EMA (European Medicines Agency)

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