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.

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

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

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

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

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

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. - glycopyrronium bromide; indacaterol maleate -

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

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

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

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.