Ireland - English - HPRA (Health Products Regulatory Authority)

orion corporation - budesonide; formoterol fumarate dihydrate - inhalation powder - 160/4.5 microgram(s) - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and budesonide

Ireland - English - HPRA (Health Products Regulatory Authority)

orion corporation - budesonide; formoterol fumarate dihydrate - inhalation powder - 320/9 microgram(s) - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and budesonide

Malta - English - Medicines Authority

orion corporation orionintie 1, fi-02200 espoo, finland - formoterol fumarate, dihydrate, budesonide - inhalation powder - formoterol fumarate dihydrate 4.5 µg budesonide 160 µg - drugs for obstructive airway diseases

Malta - English - Medicines Authority

orion corporation orionintie 1, fi-02200 espoo, finland - formoterol fumarate, dihydrate, budesonide - inhalation powder - formoterol fumarate dihydrate 9 µg budesonide 320 µg - drugs for obstructive airway diseases

Ireland - English - HPRA (Health Products Regulatory Authority)

orion corporation - budesonide; formoterol fumarate dihydrate - inhalation powder - 80/4.5 microgram(s) - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and budesonide

Malta - English - Medicines Authority

orion corporation orionintie 1, fi-02200 espoo, finland - budesonide, formoterol fumarate, dihydrate - inhalation powder - budesonide 80 µg formoterol fumarate dihydrate 4.5 µg - drugs for obstructive airway diseases

Australia - English - 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 - English - 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.