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

astrazeneca pty ltd - budesonide, quantity: 320 microgram; formoterol fumarate dihydrate, quantity: 9 microgram - inhalation, powder for - excipient ingredients: lactose monohydrate - asthma symbicort turbuhaler 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 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.

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

astrazeneca pty ltd - budesonide, quantity: 160 microgram; formoterol fumarate dihydrate, quantity: 4.5 microgram - inhalation, powder for - excipient ingredients: lactose monohydrate - asthma symbicort turbuhaler 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). symbicort 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.

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

astrazeneca pty ltd - budesonide, quantity: 80 microgram; formoterol fumarate dihydrate, quantity: 4.5 microgram - inhalation, powder for - excipient ingredients: lactose monohydrate - asthma symbicort turbuhaler 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 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.

Israel - English - 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.

Israel - English - 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.

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

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - budesonide 320ug equivalent to 400 µg metered dose;  ;  ;  ; formoterol fumarate 9ug equivalent to 12 µg metered dose;   - powder for inhalation - active: budesonide 320ug equivalent to 400 µg metered dose       formoterol fumarate 9ug equivalent to 12 µg metered dose   excipient: lactose monohydrate - symbicort turbuhaler is indicated in the treatment of asthma to achieve overall asthma control, including the prevention and relief of symptoms as well as the reduction of the risk of exacerbations. symbicort turbuhaler is suitable for any asthma severity, where the use of inhaled corticosteroids is appropriate.

Israel - English - 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

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

Malta - English - Medicines Authority

astrazeneca ab se-151 85, södertälje, sweden - formoterol, budesonide - inhalation powder - formoterol 12 µg budesonide 400 µg - drugs for obstructive airway diseases