Malta - inglese - Malta Medicines Authority

glaxo smithkline ireland limited 12, riverwalk, citywest business campus, dublin 24, ireland - salmeterol, fluticasone propionate - pressurised inhalation, suspension - salmeterol 25 µg fluticasone propionate 250 µg - drugs for obstructive airway diseases

Malta - inglese - Malta Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - salmeterol xinafoate, fluticasone propionate - pressurised inhalation, suspension - salmeterol xinafoate 25 µg fluticasone propionate 125 µg - drugs for obstructive airway diseases

Malta - inglese - Malta Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - salmeterol xinafoate, fluticasone propionate - pressurised inhalation, suspension - salmeterol xinafoate 25 µg fluticasone propionate 250 µg - drugs for obstructive airway diseases

Malta - inglese - Malta Medicines Authority

glenmark pharmaceuticals nordic ab propellergatan 2 se-211 15 malmö, sweden - salmeterol, fluticasone propionate - inhalation powder, pre-dispensed - salmeterol 50 µg fluticasone propionate 500 µg - drugs for obstructive airway diseases

Panama - inglese - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

n/a - salmeterol (xinafoato) - salmeterol (xinafoato)....25 mcg / propionato de fluticasona (micronizado)....125 mcg

Malta - inglese - Malta Medicines Authority

neofarma pharmaceuticals limited 42-46, mill street, qormi, qrm 3105, malta - salmeterol xinafoate, fluticasone propionate - inhalation powder - salmeterol xinafoate 50 µg fluticasone propionate 100 µg - drugs for obstructive airway diseases

Irlanda - inglese - HPRA (Health Products Regulatory Authority)

glaxosmithkline (ireland) limited - salmeterol xinafoate - pressurised inhalation suspension - 25 microgram

Unione Europea - inglese - EMA (European Medicines Agency)

teva b.v. - salmeterol xinafoate, fluticasone propionate - pulmonary disease, chronic obstructive; asthma - drugs for obstructive airway diseases, - aerivio spiromax is indicated for use in adults aged 18 years and older only.asthmaaerivio spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product (inhaled corticosteroid and long-acting β2 agonist) is appropriate:patients not adequately controlled on a lower strength corticosteroid combination product orpatients already controlled on a high dose inhaled corticosteroid and long-acting β2 agonist.chronic obstructive pulmonary disease (copd)aerivio spiromax is indicated for the symptomatic treatment of patients with copd, with a fev1

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

glaxosmithkline australia pty ltd - salmeterol xinafoate, quantity: 72.5 microgram/actuation (equivalent: salmeterol, qty 50 microgram/actuation); fluticasone propionate, quantity: 500 microgram/actuation - inhalation, powder for - excipient ingredients: lactose monohydrate - for the regular treatment of asthma, where the use of a combination product is appropriate. this may include:,*patients on effective maintenance doses of long-acting beta2-agonists and inhaled corticosteroids.,*patients who are symptomatic on current inhaled corticosteroid therapy.,for the symptomatic treatment of patients with severe copd (fev1<50% predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular beta-2 agonist bronchodilator therapy. pavtide is not indicated for the initiation of bronchodilator therapy in copd.

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

glaxosmithkline australia pty ltd - salmeterol xinafoate, quantity: 72.5 microgram/actuation (equivalent: salmeterol, qty 50 microgram/actuation); fluticasone propionate, quantity: 100 microgram/actuation - inhalation, powder for - excipient ingredients: lactose monohydrate - for the regular treatment of asthma, where the use of a combination product is appropriate. this may include:,*patients on effective maintenance doses of long-acting beta-2-agonists and inhaled corticosteroids.,*patients who are symptomatic on current inhaled corticosteroid therapy.,*initiation of maintenance therapy in those patients with moderate persistent asthma not adequately controlled on "as needed" reliever medication, and who have moderate/severe airway limitation and daily symptoms requiring medication every day (see clinical trials).,for the symptomatic treatment of patients with severe copd (fev1<50% predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular beta-2 agonist bronchodilator therapy. airzate is not indicated for the initiation of bronchodilator therapy in copd.