Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

astrazeneca pty ltd - budesonide, quantity: 80 microgram; formoterol fumarate dihydrate, quantity: 2.25 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.

Ausztrália - angol - 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.

Izrael - angol - 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.

Új-Zéland - angol - Medsafe (Medicines Safety Authority)

chiesi new zealand limited t/a emerge health - budesonide 3mg - modified release capsule - 3 mg - active: budesonide 3mg excipient: acetyl tributyl citrate ethylcellulose gelatin methacrylic acid - ethyl acrylate copolymer polysorbate 80 purified talc simeticone sugar spheres triethyl citrate - entocort capsules are indicated for the induction of remission in patients with mild to moderate crohn's disease affecting the ileum and/or the ascending colon.

Izrael - angol - 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.

Izrael - angol - 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

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

astrazeneca pty ltd - budesonide, quantity: 160 microgram; formoterol fumarate dihydrate, quantity: 4.5 microgram - inhalation, pressurised - excipient ingredients: povidone; macrogol 1000; apaflurane - 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.

Ausztrália - angol - 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.

Ausztrália - angol - 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.

Ausztrália - angol - 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.