Australien - engelsk - Department of Health (Therapeutic Goods Administration)

the medicines company australia pty ltd - bivalirudin -

Den Europæiske Union - engelsk - EMA (European Medicines Agency)

teva b.v. - salmeterol xinafoate, fluticasone propionate - pulmonary disease, chronic obstructive; asthma - drugs for obstructive airway diseases, - aerivio spiromax is indicated for use in adults aged 18 years and older only.asthmaaerivio spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product (inhaled corticosteroid and long-acting β2 agonist) is appropriate:patients not adequately controlled on a lower strength corticosteroid combination product orpatients already controlled on a high dose inhaled corticosteroid and long-acting β2 agonist.chronic obstructive pulmonary disease (copd)aerivio spiromax is indicated for the symptomatic treatment of patients with copd, with a fev1

Den Europæiske Union - engelsk - EMA (European Medicines Agency)

teva b.v. - salmeterol, fluticasone propionate - pulmonary disease, chronic obstructive; asthma - drugs for obstructive airway diseases, - airexar spiromax is indicated for use in adults aged 18 years and older only.asthmaairexar spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product (inhaled corticosteroid and long-acting β2 agonist) is appropriate:- patients not adequately controlled on a lower strength corticosteroid combination productor- patients already controlled on a high dose inhaled corticosteroid and long-acting β2 agonist.chronic obstructive pulmonary disease (copd)airexar spiromax is indicated for the symptomatic treatment of patients with copd, with a fev1

Den Europæiske Union - engelsk - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol fumarate dihydrate - pulmonary disease, chronic obstructive; asthma - drugs for obstructive airway diseases, - asthma biresp 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.copdbiresp 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)

Den Europæiske Union - engelsk - 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)

Den Europæiske Union - engelsk - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol fumarate dihydrate - pulmonary disease, chronic obstructive; asthma - drugs for obstructive airway diseases, - vylaer spiromax is indicated in adults 18 years of age and older only.asthmavylaer spiromax is indicated in 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.copdsymptomatic treatment of patients with severe copd (fev1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.

Australien - engelsk - APVMA (Australian Pesticides and Veterinary Medicines Authority)

oriental(luzhou) agrochemicals co ltd - carfentrazone-ethyl; n-methyl-2-pyrrolidone; liquid hydrocarbon - emulsifiable concentrate - carfentrazone-ethyl ungrouped active 240.0 g/l; n-methyl-2-pyrrolidone solvent other 20.0 g/l; liquid hydrocarbon solvent other 736.0 g/l - herbicide

Australien - engelsk - 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.

Australien - engelsk - 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.

Australien - engelsk - 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: biresp 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 and exacerbations (see section 4.2 dose and method of administration).,biresp 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): biresp 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. biresp spiromax is not indicated for the initiation of bronchodilator therapy in copd.