Ireland - English - HPRA (Health Products Regulatory Authority)

imed healthcare ltd. - formoterol fumatrate dihydrate; budesonide - inhalation powder - 200 µg/6 µg/inhalation - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and budesonide

Ireland - English - HPRA (Health Products Regulatory Authority)

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

Australia - English - 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 rilast 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) rilast rapihaler 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. 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, pressurised - excipient ingredients: povidone; macrogol 1000; apaflurane - asthma 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) 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. not indicated for the initiation of bronchodilator therapy in copd.

Ireland - English - HPRA (Health Products Regulatory Authority)

astrazeneca uk limited - budesonide; formoterol fumatrate dihydrate - powder for inhalation - 200/6 microgram(s) - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics

Ireland - English - HPRA (Health Products Regulatory Authority)

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

Ireland - English - HPRA (Health Products Regulatory Authority)

astrazeneca uk limited - budesonide; formoterol fumatrate dihydrate - powder for inhalation - 400/12 microgram(s) - o3ak07

Ireland - English - HPRA (Health Products Regulatory Authority)

imbat limited - budesonide, formoterol fumatrate dihydrate - powder for inhalation - 100mcg/6 mcg/dose - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics

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

teva pharma australia pty ltd - budesonide, quantity: 320 microgram; formoterol fumarate dihydrate, quantity: 9 microgram - inhalation, powder for - excipient ingredients: lactose monohydrate - asthma: duoresp spiromax is indicated in adults (18 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).,duoresp spiromax is not indicated in children and adolescents under the age of 18 years as the 100/6 dose is not available.,chronic obstructive pulmonary disease (copd): duoresp spiromax is indicated for the symptomatic treatment of moderate to severe copd (fev1=50% predicted normal) in adults with frequent symptoms despite long-acting bronchodilator use, and/or history of recurrent exacerbations. duoresp spiromax is not indicated for the initiation of bronchodilator therapy in copd.

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

teva pharma australia pty ltd - budesonide, quantity: 160 microgram; formoterol fumarate dihydrate, quantity: 4.5 microgram - inhalation, powder for - excipient ingredients: lactose monohydrate - asthma: duoresp spiromax is indicated in adults (18 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).,duoresp spiromax is not indicated in children and adolescents under the age of 18 years as the 100/6 dose is not available.,chronic obstructive pulmonary disease (copd): duoresp spiromax is indicated for the symptomatic treatment of moderate to severe copd (fev1=50% predicted normal) in adults with frequent symptoms despite long-acting bronchodilator use, and/or history of recurrent exacerbations. duoresp spiromax is not indicated for the initiation of bronchodilator therapy in copd.