Irlanda - inglese - HPRA (Health Products Regulatory Authority)

ltt pharma limited - budesonide, formoterol fumarate dihydrate - powder for inhalation - 400/12 mcg/dose - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics - adrenergics and other drugs for obstructive airway diseases - it is indicated in adults and adolescents aged 12 to17 years for the regular treatment of asthma and for the symptomatic treatment of patients with severe copd

Israele - inglese - 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.

Israele - inglese - 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

Stati Uniti - inglese - NLM (National Library of Medicine)

astrazeneca pharmaceuticals lp - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x), formoterol fumarate (unii: w34shf8j2k) (formoterol - unii:5zz84gcw8b) - budesonide 160 ug - symbicort is indicated for the treatment of asthma in patients 6 years of age and older. symbicort 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: symbicort 160/4.5 is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (copd) including chronic bronchitis and/or emphysema. symbicort 160/4.5 is also indicated to reduce exacerbations of copd. symbicort 160/4.5 is the only strength indicated for the treatment of copd. important limitations of use: the use of symbicort is contraindicated in the following conditions: risk summary there are no adequate and well-controlled studies of symbicort or one of its individual components, formoterol fumarate, in pregnant women; however studies are available for t

Stati Uniti - inglese - 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

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

orion pharma (aus) pty limited - budesonide, quantity: 320 microgram/actuation; formoterol fumarate dihydrate, quantity: 9 microgram/actuation - inhalation, powder for - excipient ingredients: lactose monohydrate - asthma,bufomix easyhaler 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),bufomix easyhaler is indicated for the symptomatic treatment of moderate to severe copd (fev1 less than or equal to 50 percent predicted normal) in adults with frequent symptoms despite long-acting bronchodilator use, and/or a history of recurrent exacerbations. bufomix easyhaler is not indicated for the initiation of bronchodilator therapy in copd.

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

orion pharma (aus) pty limited - budesonide, quantity: 160 microgram/actuation; formoterol fumarate dihydrate, quantity: 4.5 microgram/actuation - inhalation, powder for - excipient ingredients: lactose monohydrate - asthma,bufomix easyhaler 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),bufomix easyhaler is indicated for the symptomatic treatment of moderate to severe copd (fev1 less than or equal to 50 percent predicted normal) in adults with frequent symptoms despite long-acting bronchodilator use, and/or a history of recurrent exacerbations. bufomix easyhaler is not indicated for the initiation of bronchodilator therapy in copd.

Kenya - inglese - Pharmacy and Poisons Board

budesonide+ formoterol fumarate dihydrate - inhalation vapour - budesonide 200mcg + formoterol fumarate dihydrate… - adrenergics inhalants: adrenergics and other

Israele - inglese - 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.

Irlanda - inglese - HPRA (Health Products Regulatory Authority)

astrazeneca ab - budesonide; formoterol fumatrate dihydrate - inhalation powder - 400 mcg/12 microgram(s) - formoterol and budesonide