Australia - English - Department of Health (Therapeutic Goods Administration)

a menarini australia pty ltd - aclidinium bromide, quantity: 0.4 mg/actuation; formoterol fumarate dihydrate, quantity: 0.012 mg/actuation - inhalation, powder for - excipient ingredients: lactose monohydrate - brimica genuair 340/12 is indicated as a long-term twice daily maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (copd).

New Zealand - English - Medsafe (Medicines Safety Authority)

a. menarini new zealand pty ltd - aclidinium bromide 0.4mg equivalent to 0.340mg aclidinium; formoterol fumarate dihydrate 0.012mg - powder for inhalation - 340/12mcg - active: aclidinium bromide 0.4mg equivalent to 0.340mg aclidinium formoterol fumarate dihydrate 0.012mg excipient: lactose monohydrate - a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (copd).

Australia - English - Department of Health (Therapeutic Goods Administration)

astrazeneca pty ltd - budesonide, quantity: 160 microgram/actuation; formoterol fumarate dihydrate, quantity: 5 microgram/actuation; glycopyrronium bromide, quantity: 9 microgram/actuation (equivalent: glycopyrronium, qty 7.2 microgram/actuation) - inhalation, pressurised - excipient ingredients: calcium chloride dihydrate; distearoylphosphatidylcholine; norflurane - maintenance treatment to prevent exacerbations and relieve symptoms in adults with moderate, severe, or very severe chronic obstructive pulmonary disease (copd) who require treatment with a combination of an inhaled corticosteroid (ics), a long-acting beta2-agonist (laba), and a long-acting muscarinic antagonist (lama). breztri aerosphere 160/7.2/5 is not indicated for the initiation of therapy in copd.

Australia - English - Department of Health (Therapeutic Goods Administration)

astrazeneca pty ltd - budesonide, quantity: 160 microgram/actuation; formoterol fumarate dihydrate, quantity: 5 microgram/actuation; glycopyrronium bromide, quantity: 9 microgram/actuation (equivalent: glycopyrronium, qty 7.2 microgram/actuation) - inhalation, pressurised - excipient ingredients: calcium chloride dihydrate; distearoylphosphatidylcholine; norflurane - maintenance treatment to prevent exacerbations and relieve symptoms in adults with moderate, severe, or very severe chronic obstructive pulmonary disease (copd) who require treatment with a combination of an inhaled corticosteroid (ics), a long-acting beta2-agonist (laba), and a long-acting muscarinic antagonist (lama). breztri aerosphere 160/7.2/5 is not indicated for the initiation of therapy in copd.

United States - English - NLM (National Library of Medicine)

astrazeneca pharmaceuticals lp - aclidinium bromide (unii: uqw7uf9n91) (aclidinium - unii:k17vy42f6c), formoterol fumarate (unii: w34shf8j2k) (formoterol - unii:5zz84gcw8b) - duaklir pressair is a combination of aclidinium bromide (an anticholinergic) and formoterol fumarate (a laba) indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (copd). limitations of use: duaklir pressair is not indicated for the relief of acute bronchospasm or for the treatment of asthma [see warnings and precautions (5.1, 5.4)] . use of a long-acting beta2 -adrenergic agonist (laba), including formoterol fumarate, one of the active ingredients in duaklir pressair, without an inhaled corticosteroid is contraindicated in patients with asthma [see warnings and precautions (5.1)] . duaklir pressair is not indicated for the treatment of asthma. duaklir pressair is contraindicated in patients with: risk summary there are no adequate and well-controlled studies of duaklir pressair or its individual components, formoterol fumarate or aclidinium bromide, in pregnant women to inform drug-associated risks. no adverse developmental effects were seen with inhalation administr

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

colorama pharmaceuticals ltd - formoterol fumarate dihydrate; aclidinium bromide - inhalation powder - 11.8microgram/1dose ; 396microgram/1dose

European Union - English - EMA (European Medicines Agency)

covis pharma europe b.v. - aclidinium bromide, formoterol fumarate dihydrate - pulmonary disease, chronic obstructive - drugs for obstructive airway diseases, - duaklir genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (copd).

Canada - English - Health Canada

covis pharma gmbh - aclidinium bromide; formoterol fumarate dihydrate - powder (metered dose) - 400mcg; 12mcg - aclidinium bromide 400mcg; formoterol fumarate dihydrate 12mcg - antimuscarinics antispasmodics

European Union - English - EMA (European Medicines Agency)

covis pharma europe b.v. - formoterol fumarate dihydrate, aclidinium bromide - pulmonary disease, chronic obstructive - drugs for obstructive airway diseases, - brimica genuair is indicated as a maintenance bronchodilator treatment for airflow obstruction and relief of symptoms in adult patients with chronic obstructive pulmonary disease (copd).

Israel - English - Ministry of Health

astrazeneca (israel) ltd - aclidinium as bromide; formoterol fumarate dihydrate - powder for inhalation - formoterol fumarate dihydrate 11.8 mcg; aclidinium as bromide 340 mcg - aclidinium bromide - maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (copd)