Singapore - English - HSA (Health Sciences Authority)

mundipharma pharmaceuticals pte. ltd. - fluticasone propionate; formoterol fumarate dihydrate - aerosol, metered - 50 mcg/actuation - fluticasone propionate 50 mcg/actuation; formoterol fumarate dihydrate 5 mcg/actuation

Singapore - English - HSA (Health Sciences Authority)

mundipharma pharmaceuticals pte. ltd. - fluticasone propionate; formoterol fumarate dihydrate - aerosol, metered - 125 mcg/actuation - fluticasone propionate 125 mcg/actuation; formoterol fumarate dihydrate 5 mcg/actuation

Singapore - English - HSA (Health Sciences Authority)

mundipharma pharmaceuticals pte. ltd. - fluticasone propionate; formoterol fumarate dihydrate - aerosol, metered - 250 mcg/actuation - fluticasone propionate 250 mcg/actuation; formoterol fumarate dihydrate 10 mcg/actuation

European Union - English - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol fumarate dihydrate - pulmonary disease, chronic obstructive; asthma - drugs for obstructive airway diseases, - budesonide/formoterol teva is indicated in adults 18 years of age and older only.asthmabudesonide/formoterol teva is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.orin patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.copdsymptomatic treatment of patients with severe copd (fev1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.

European Union - English - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol - asthma - drugs for obstructive airway diseases, - budesonide/formoterol teva pharma b.v. is indicated in adults 18 years of age and older only.asthmabudesonide/formoterol teva pharma b.v. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: orin patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists. 

European Union - English - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol fumarate dihydrate - pulmonary disease, chronic obstructive; asthma - drugs for obstructive airway diseases, - vylaer spiromax is indicated in adults 18 years of age and older only.asthmavylaer spiromax is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.orin patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.copdsymptomatic treatment of patients with severe copd (fev1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.

Israel - English - Ministry of Health

astrazeneca (israel) ltd - budesonide micronized; formoterol fumarate - powder for inhalation - budesonide micronized 80 mcg/dose; formoterol fumarate 4.5 mcg/dose - formoterol and budesonide - formoterol and other drugs for obstructive airway diseases - symbicort turbuhaler is indicated in the regular treatment of asthma where use of a combination (inhaled corticosteroid and long acting beta-agonist) is appropriate: - patients not adequaterly controlled with inhaled corticosteroids and " as needed" inhaled short acting beta2- agonists. - or patients already adequately controlled on both inhaled corticosteroids and long acting beta2- agonists. note: symbicort turbuhaler 80/4.5 mcg/dose is not appropriate in patients with severe asthma.

Israel - English - Ministry of Health

astrazeneca (israel) ltd - budesonide micronized; formoterol fumarate - powder for inhalation - budesonide micronized 160 mcg/dose; formoterol fumarate 4.5 mcg/dose - formoterol and budesonide - formoterol and other drugs for obstructive airway diseases - asthmasymbicort turbuhaler 160/4.5 mcg/dose is indicated in adults and adolescents (12 years and older), for the treatment of asthma, to achieve overall asthma control, including the relief of symptoms and the reduction of the risk of exacerbations.chronic obstructive pulmonary disease (copd)symbicort turbuhaler 160/4.5 mcg/dose is indicated in adults, aged 18 years and older, for the symptomatic treatment of patients with copd with forced expiratory volume in 1 second (fev1) < 70% predicted normal (post-bronchodilator) and an exacerbation history despite regular bronchodilator therapy.

Israel - English - Ministry of Health

astrazeneca (israel) ltd - budesonide micronized; formoterol fumarate - powder for inhalation - budesonide micronized 320 mcg/dose; formoterol fumarate 9 mcg/dose - formoterol and budesonide - formoterol and other drugs for obstructive airway diseases - symbicort turbuhaler 320/9 mcg/dose is indicated in adults and adolescents, age 12 -17 for the regular treatment of asthma where use of a combination (inhaled corticosteroid and long acting β2 adrenoceptor-agonist) is appropriate:-patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short acting β2 adrenoceptor-agonists.or- patients already adequately controlled on both inhaled corticosteroids and long acting β2 adrenoceptoragonists.chronic obstructive pulmonary disease (copd)symbicort turbuhaler 320/9 mcg/dose is indicated in adults, aged 18 years and older, for the symptomatic treatment of patients with copd with forced expiratory volume in i second (fev1) < 70% predicted normal (post-bronchodilator) and an exacerbation history despite regular bronchodilator therapy

Malta - English - Medicines Authority

orion corporation orionintie 1, fi-02200 espoo, finland - formoterol fumarate, dihydrate, budesonide - inhalation powder - formoterol fumarate dihydrate 4.5 µg budesonide 160 µg - drugs for obstructive airway diseases