Europska Unija - engleski - EMA (European Medicines Agency)

novartis europharm limited - indacaterol, glycopyrronium bromide - pulmonary disease, chronic obstructive - adrenergics in combinations with anticholinergics incl. triple combinations with corticosteroids, drugs for obstructive airway diseases, - ultibro breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (copd).

Novi Zeland - engleski - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - indacaterol maleate 0.389mg;  ;  ;   - powder filled inhalation capsule - 300 mcg - active: indacaterol maleate 0.389mg       excipient: gelatin lactose monohydrate opacode - 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.

Australija - engleski - 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.

Kanada - engleski - Health Canada

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

Europska Unija - engleski - EMA (European Medicines Agency)

novartis europharm limited - indacaterol maleate - pulmonary disease, chronic obstructive - drugs for obstructive airway diseases, - hirobriz breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease.

Europska Unija - engleski - EMA (European Medicines Agency)

novartis europharm limited  - indacaterol maleate - pulmonary disease, chronic obstructive - drugs for obstructive airway diseases, - oslif breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease.

Europska Unija - engleski - EMA (European Medicines Agency)

novartis europharm limited  - indacaterol maleate - pulmonary disease, chronic obstructive - drugs for obstructive airway diseases, - onbrez breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease.

Velika Britanija - engleski - MHRA (Medicines & Healthcare Products Regulatory Agency)

novartis pharmaceuticals uk ltd - indacaterol maleate - inhalation powder - 300microgram

Velika Britanija - engleski - MHRA (Medicines & Healthcare Products Regulatory Agency)

novartis pharmaceuticals uk ltd - indacaterol maleate - inhalation powder - 150microgram

Armenija - engleski - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

novartis farmaceutica s.a. - indacaterol (indacaterol maleate) - powder for inhalation, hard capsules - 300mcg