Malta - English - 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 - English - Medicines Authority

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

Israel - English - 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.

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

mylan pharmaceuticals inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x), formoterol fumarate (unii: w34shf8j2k) (formoterol - unii:5zz84gcw8b) - breyna is indicated for the treatment of asthma in patients 6 years of age and older. breyna should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ics) or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long-acting beta2 -adrenergic agonist (laba). important limitations of use: breyna 160 mcg/4.5 mcg is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (copd) including chronic bronchitis and/or emphysema. breyna 160 mcg/4.5 mcg is also indicated to reduce exacerbations of copd. breyna 160 mcg/4.5 mcg is the only strength indicated for the treatment of copd. important limitations of use: the use of breyna is contraindicated in the following conditions: there are no adequate and well-controlled studies of budesonide and formoterol fumarate dihydrate inhalation aerosol or one of its individual components, formoterol fumarate, in pre

Ireland - English - HPRA (Health Products Regulatory Authority)

astrazeneca uk limited - budesonide micronised; formoterol fumarate dihydrate (micronised) - pressurised inhalation, suspension - 200/6 mcg/acutuation - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and budesonide

Ireland - English - HPRA (Health Products Regulatory Authority)

astrazeneca ab - budesonide micronised; formoterol fumarate dihydrate (micronised) - pressurised inhalation, suspension - 200 mcg/6 microgram(s) - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and budesonide

Ireland - English - 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

Ireland - English - HPRA (Health Products Regulatory Authority)

primecrown 2010 limited - budesonide dihydrate; formoterol fumarate dihydrate - inhalation powder - 400/12 µg/µg - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and budesonide

Ireland - English - HPRA (Health Products Regulatory Authority)

pco manufacturing ltd. - formoterol fumatrate dihydrate; budesonide - inhalation powder - 400/12 microgram(s)/dose - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and budesonide

Ireland - English - HPRA (Health Products Regulatory Authority)

pco manufacturing ltd. - budesonide; formoterol fumatrate dihydrate - inhalation powder - 200 µg/6 microgram(s)/dose - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and budesonide