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

siegfried barbera s.l. - indacaterol (indacaterol maleate), glycopyrronium bromide, mometasone fuora - powder for inhalation, capsules hard - 150mcg+ 50mcg+ 160mcg

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

novartis pharma k.k. - indacaterol maleate - yellowish colorless and transparent inhalation capsule (major axis: 15.9 mm, minor axis: 5.8 mm)

Singapur - engleski - HSA (Health Sciences Authority)

novartis (singapore) pte ltd - indacaterol maleate 0.194mg eqv indacaterol (micronized) - capsule - 0.150mg

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

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

Australija - engleski - Department of Health (Therapeutic Goods Administration)

grand medical pty ltd - indacaterol acetate, quantity: 173 microgram (equivalent: indacaterol, qty 150 microgram); mometasone furoate, quantity: 160 microgram; glycopyrronium bromide, quantity: 63 microgram (equivalent: glycopyrronium, qty 50 microgram) - capsule, hard - excipient ingredients: lactose monohydrate; magnesium stearate - zimbus 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.

Singapur - engleski - 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

Australija - engleski - Department of Health (Therapeutic Goods Administration)

grand medical pty ltd - indacaterol acetate, quantity: 173 microgram (equivalent: indacaterol, qty 150 microgram); mometasone furoate, quantity: 320 microgram - capsule, hard - excipient ingredients: lactose monohydrate - bemrist breezhaler is indicated as a once-daily maintenance treatment of asthma in adults and adolescents 12 years of age and older where use of a combination of long-acting beta2-agonist and inhaled corticosteroid is appropriate:,- patients not adequately controlled with inhaled corticosteroids and "as needed" inhaled short-acting beta2-agonists or,- patients not adequately controlled with long-acting beta2-agonists and low dose of inhaled corticosteroids and "as needed" inhaled short-acting beta2-agonists

Malezija - engleski - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

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

Kanada - engleski - 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

Europska Unija - engleski - EMA (European Medicines Agency)

novartis europharm limited - glycopyrronium bromide, indacaterol (acetate), mometasone furoate - asthma - drugs for obstructive airway diseases, - maintenance treatment of asthma in adults whose disease is not adequately controlled.