Unione Europea - inglese - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol fumarate dihydrate - pulmonary disease, chronic obstructive; asthma - drugs for obstructive airway diseases, - asthma duoresp spiromax is indicated in adults and adolescents (12 years and older) for the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β₂ adrenoceptor agonist) is appropriate:in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β₂ adrenoceptor agonists.orin patients already adequately controlled on both inhaled corticosteroids and long-acting β₂ adrenoceptor agonists.copdduoresp spiromax 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)

Regno Unito - inglese - MHRA (Medicines & Healthcare Products Regulatory Agency)

astrazeneca uk ltd - budesonide; formoterol fumarate dihydrate - inhalation powder - 100microgram/1dose ; 6microgram/1dose

Regno Unito - inglese - MHRA (Medicines & Healthcare Products Regulatory Agency)

astrazeneca uk ltd - budesonide; formoterol fumarate dihydrate - inhalation powder - 200microgram/1dose ; 6microgram/1dose

Irlanda - inglese - HPRA (Health Products Regulatory Authority)

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

Regno Unito - inglese - MHRA (Medicines & Healthcare Products Regulatory Agency)

astrazeneca uk ltd - budesonide; formoterol fumarate dihydrate - inhalation powder - 400microgram/1dose ; 12microgram/1dose

Regno Unito - inglese - MHRA (Medicines & Healthcare Products Regulatory Agency)

orion pharma (uk) ltd - budesonide; formoterol fumarate dihydrate - inhalation powder - 400microgram/1dose ; 12microgram/1dose

Regno Unito - inglese - MHRA (Medicines & Healthcare Products Regulatory Agency)

astrazeneca uk ltd - formoterol fumarate dihydrate; budesonide - pressurised inhalation - 6microgram/1dose ; 200microgram/1dose

Malesia - inglese - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

astrazeneca sdn. bhd. - budesonide; formoterol fumarate dihydrate -

Malesia - inglese - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

astrazeneca sdn. bhd. - budesonide; formoterol fumarate dihydrate -

Irlanda - inglese - HPRA (Health Products Regulatory Authority)

ltt pharma limited - budesonide, formoterol fumarate dihydrate - powder for inhalation - 200/6 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 to 17 years for the regular treatment of asthma and for the symptomatic treatment of patients with severe copd