Ireland - English - HPRA (Health Products Regulatory Authority)

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

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. 

Australia - English - 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 - English - 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. pavtide is not indicated for the initiation of bronchodilator therapy in copd.

United States - English - NLM (National Library of Medicine)

physicians total care, inc. - formoterol fumarate (unii: p3t5qa5j9n) (formoterol - unii:5zz84gcw8b) - formoterol fumarate 12 ug - foradil aerolizer is indicated for the treatment of asthma and in the prevention of bronchospasm only as concomitant therapy with a long-term asthma control medication, such as an inhaled corticosteroid, in adults and children 5 years of age and older with reversible obstructive airways disease, including patients with symptoms of nocturnal asthma.       long-acting beta2 -adrenergic agonists (laba), such as formoterol, the active ingredient in foradil aerolizer, increase the risk of asthma-related death (see warnings). use of foradil aerolizer for the treatment of asthma without concomitant use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated. use foradil aerolizer only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid. once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g

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

astrazeneca pty ltd - formoterol fumarate dihydrate, quantity: 2.25 microgram; budesonide, quantity: 40 microgram - inhalation, pressurised - excipient ingredients: apaflurane; macrogol 1000; povidone - asthma symbicort rapihaler 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 (see section 4.2 dose and method of administration). chronic obstructive pulmonary disease (copd) symbicort 200/6 is indicated for the symptomatic treatment of moderate to severe copd (fev1 < or = 50% predicted normal) in adults with frequent symptoms despite long-acting bronchodilator use, and/or a history of recurrent exacerbations. symbicort is not indicated for the initiation of bronchodilator therapy in copd.

United States - English - NLM (National Library of Medicine)

mylan specialty l.p. - formoterol fumarate (unii: w34shf8j2k) (formoterol - unii:5zz84gcw8b) - formoterol fumarate anhydrous 20 ug in 2 ml - perforomist (formoterol fumarate) inhalation solution is indicated for the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and emphysema. perforomist inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see warnings and precautions (5.2)]. perforomist inhalation solution is not indicated to treat asthma. the safety and effectiveness of perforomist inhalation solution in asthma have not been established. use of a laba, including perforomist, without an inhaled corticosteroid is contraindicated in patients with asthma [see warnings and precautions (5.1)] . perforomist is not indicated for the treatment of asthma. there are limited available data with perforomist inhalation solution use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. beta-agonists may interfere w

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

glaxosmithkline australia pty ltd - salmeterol xinafoate, quantity: 72.5 microgram/actuation (equivalent: salmeterol, qty 50 microgram/actuation) - inhalation, powder for - excipient ingredients: lactose monohydrate - indications as at 5th october 1995: long-term regular treatment of reversible airways obstruction in asthma (including nocturnal asthma and exercise-induced asthma), in patients aged four years or more who are receiving inhaled or oral corticosteroids. it should not be used in patients whose asthma can be managed by occasional use of short-acting inhaled beta 2 agonists. indication as at 13th january 1997 - adults: salmeterol is suitable for long-term regular treatment of reversible airways obstruction in asthma (including nocturnal asthma and exercise-induced asthma), in patients who are receiving inhaled or oral corticosteroids. it should not be used in patients whose asthma can be managed by occasional use of short-acting inhaled beta-2 agonists. salmeterol also provides long-lasting (12 hours) bronchodilation for the reversible component of airways obstruction due to chronic obstructive pulmonary disease (copd). children aged 4 years and over: long-term regular treatment of reversible airways obstruction in asthma (including nocturnal asthma and exercised-induced asthma), in patients who are receiving inhaled or oral corticosteroids. it should not be used in patients whose asthma can be managed by occasional use of short-acting inhaled beta-2 agonists.

European Union - English - EMA (European Medicines Agency)

teva pharma b.v.  - budesonide, formoterol fumarate dihydrate - asthma; pulmonary disease, chronic obstructive - 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:-in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.or-in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.copdsymptomatic treatment of patients with copd with forced expiratory volume in 1 second (fev1)