Ísrael - enska - Ministry of Health

kamada ltd, israel - beclometasone dipropionate anhydrous; formoterol fumarate dihydrate - pressurised solution - formoterol fumarate dihydrate 6 mcg/actuation; beclometasone dipropionate anhydrous 200 mcg/actuation - formoterol and beclometasone - foster 200/6 is indicated in the regular treatment of asthma in adults where use of a combination product (inhaled corticosteroid and long-acting beta2-agonist) is appropriate:- patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled rapid-acting beta2-agonist or- patients already adequately controlled on both inhaled corticosteroids and long-acting beta2-agonists.

Malta - enska - Medicines Authority

astrazeneca ab se-151 85, södertälje, sweden - formoterol fumarate, dihydrate - inhalation powder - formoterol fumarate dihydrate 4.5 µg - drugs for obstructive airway diseases

Malta - enska - Medicines Authority

astrazeneca ab se-151 85, södertälje, sweden - formoterol fumarate, dihydrate - inhalation powder - formoterol fumarate dihydrate 9 µg - drugs for obstructive airway diseases

Írland - enska - HPRA (Health Products Regulatory Authority)

merit pharmaceuticals limited - budesonide dihydrate; formoterol fumarate dihydrate - inhalation powder - 400/12 µg/µg - formoterol and budesonide

Ísrael - enska - Ministry of Health

kamada ltd, israel - beclometasone dipropionate; formoterol fumarate dihydrate; glycopyrronium as bromide - pressurised solution - glycopyrronium as bromide 9 mcg/delivered dose; formoterol fumarate dihydrate 5.2 mcg/delivered dose; beclometasone dipropionate 87.4 mcg/delivered dose - formoterol, glycopyrronium bromide and beclometasone - copd 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 a combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist. asthma maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and medium dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.…

Bandaríkin - enska - NLM (National Library of Medicine)

rhodes pharmaceuticals l.p. - formoterol fumarate (unii: w34shf8j2k) (formoterol - unii:5zz84gcw8b) - 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. formoterol fumarate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see warnings and precautions (5.2)]. formoterol fumarate inhalation solution is not indicated to treat asthma. the safety and effectiveness of formoterol fumarate inhalation solution in asthma have not been established. use of a laba, including formoterol fumarate, without an inhaled corticosteroid is contraindicated in patients with asthma [see warnings and precautions (5.1)]. formoterol fumarate is not indicated for the treatment of asthma. risk summary there are limited available data with formoterol fumarate inhalation solution use in pregnant women to inform a drug-associated risk of adverse developmen

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

mundipharma pty ltd - formoterol fumarate dihydrate, quantity: 0.8 mg; fluticasone propionate, quantity: 8 mg - inhalation, pressurised - excipient ingredients: ethanol absolute; sodium cromoglycate; apaflurane - flutiform inhaler is indicated for the regular maintenance treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long-acting beta2-agonist) is appropriate. this includes patients not adequately controlled with inhaled corticosteroids and inhaled short-acting beta2-agonist on an ?as required? basis.

Evrópusambandið - enska - 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. 

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - formoterol fumarate, quantity: 12 microgram - inhalation, powder for - excipient ingredients: lactose monohydrate; gelatin; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; shellac; sulfuric acid - for long-term, regular treatment of reversible airways obstruction in asthma (including nocturnal asthma and exercised-induced asthma) in patients aged 5 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. indications as at 27 march 2001: for the long-term regular treatment of reversible airways obstruction in asthma (including nocturnal asthma and exercise-induced asthma) in patients aged 5 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. for the prophylaxis and treatment of bronchoconstriction in patients with reversible or irreversible chronic obstructive pulmonary disease (copd).

Írland - enska - HPRA (Health Products Regulatory Authority)

primecrown 2010 limited - budesonide dihydrate; formoterol fumarate dihydrate - inhalation powder - 200/6 µg/µg - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and budesonide