Ireland - English - HPRA (Health Products Regulatory Authority)

orion corporation - budesonide; formoterol fumarate dihydrate - inhalation powder - 160/4.5 microgram(s) - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and budesonide

Ireland - English - HPRA (Health Products Regulatory Authority)

orion corporation - budesonide; formoterol fumarate dihydrate - inhalation powder - 320/9 microgram(s) - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and budesonide

Ireland - English - HPRA (Health Products Regulatory Authority)

imed healthcare ltd. - formoterol fumarate dihydrate; budesonide - inhalation powder - 400 µg /12 µg/inhalation - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and budesonide - adrenergics and other drugs for obstructive airway diseases. - it is indicated: in adults and adolescents aged 12 to 17 years for the regular treatment of asthma where use of a combination is appropriate; in adults, aged 18 years and older, for the symptomatic treatment of patients with severe copd and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators

Ireland - English - HPRA (Health Products Regulatory Authority)

orion corporation - budesonide; formoterol fumarate dihydrate - inhalation powder - 80/4.5 microgram(s) - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and budesonide

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, - asthma biresp spiromax is indicated in adults and adolescents (12 years and older) for 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.copdbiresp spiromax 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)

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, - asthma duoresp spiromax is indicated in adults and adolescents (12 years and older) for 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.copdduoresp spiromax 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)

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.

Ireland - English - HPRA (Health Products Regulatory Authority)

rowex ltd - budesonide; formoterol fumarate dihydrate - inhalation powder, pre-dispensed - 160 microg/4.5 mcg/dose - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and budesonide

European Union - English - EMA (European Medicines Agency)

astrazeneca ab - budesonide, formoterol fumarate dihydrate, glycopyrronium bromide - pulmonary disease, chronic obstructive - drugs for obstructive airway diseases, - riltrava aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (copd) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2 agonist or combination of a long-acting beta2 agonist and a long-acting muscarinic antagonist (for effects on symptoms control and prevention of exacerbations see section 5.1).

Ireland - English - HPRA (Health Products Regulatory Authority)

astrazeneca uk limited - formoterol fumarate dihydrate; budesonide - powder for inhalation - 100/6 microgram(s) - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics