New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - fluticasone furoate 100ug;  ; umeclidinium bromide 74.2ug equivalent to umeclidinium 62.5 mcg (free cation);  ; vilanterol trifenatate 40ug equivalent to 25 mcg of vilanterol (free base);   - powder for inhalation - active: fluticasone furoate 100ug   umeclidinium bromide 74.2ug equivalent to umeclidinium 62.5 mcg (free cation)   vilanterol trifenatate 40ug equivalent to 25 mcg of vilanterol (free base)   excipient: lactose monohydrate magnesium stearate - trelegy ellipta is indicated for the maintenance treatment of adults with moderate to severe chronic obstructive pulmonary disease (copd) who require treatment with a long-acting muscarinic receptor antagonist (lama) + long-acting beta2-receptor agonist (laba) + inhaled corticosteroid (ics). trelegy ellipta should not be used for the initiation of copd treatment.

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

glaxosmithkline australia pty ltd - umeclidinium bromide, quantity: 74.2 microgram (equivalent: umeclidinium, qty 62.5 microgram); vilanterol trifenatate, quantity: 40 microgram (equivalent: vilanterol, qty 25 microgram) - inhalation, powder for - excipient ingredients: magnesium stearate; lactose monohydrate - anoro ellipta is indicated as a long-term once daily maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (copd).

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

glaxosmithkline uk ltd - umeclidinium bromide - inhalation powder - 65microgram/1dose

European Union - English - EMA (European Medicines Agency)

glaxosmithkline trading services limited - umeclidinium bromide - pulmonary disease, chronic obstructive - drugs for obstructive airway diseases, - rolufta is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (copd).,

Singapore - English - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - umeclidinium bromide 74.2 mcg (micronised) eqv. umeclidinium - powder, metered - umeclidinium bromide 74.2 mcg (micronised) eqv. umeclidinium 62.5 mcg/dose

Canada - English - Health Canada

glaxosmithkline inc - vilanterol (vilanterol trifenatate); umeclidinium (umeclidinium bromide) - powder - 25mcg; 62.5mcg - vilanterol (vilanterol trifenatate) 25mcg; umeclidinium (umeclidinium bromide) 62.5mcg - antimuscarinics antispasmodics

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - umeclidinium as bromide - powder for inhalation - umeclidinium as bromide 55 mcg - umeclidinium bromide - incruse is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (copd).

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

glaxosmithkline uk ltd - vilanterol trifenatate; umeclidinium bromide - inhalation powder - 22microgram/1dose ; 65microgram/1dose

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

glaxosmithkline pharmaceutical sdn. bhd. - vilanterol trifenatate; umeclidinium bromide -

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

glaxosmithkline uk ltd - fluticasone furoate; vilanterol trifenatate; umeclidinium bromide - inhalation powder - 92microgram/1dose ; 22microgram/1dose ; 65microgram/1dose