Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

laboratoires smb s.a. rue de la pastorale 26-28 b-1080 brussel (belgiË) - budesonide 300 µg/stuk ; salmeterolxinafoaat 36,3 µg/stuk samenstelling overeenkomend met ; salmeterol 25 µg/stuk - inhalatiepoeder in harde capsule - ammonia (e 527) ; carrageenan (e 407) ; hypromellose (e 464) ; ijzeroxide zwart (e 172) ; kaliumchloride ; lactose 0-water ; lactose 1-water ; propyleenglycol (e 1520) ; schellak glaze, gedeeltelijk veresterd ; zwarte inkt, - salmeterol and budesonide

België - Nederlands - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

laboratoires s.m.b. sa-nv - budesonide 150 µg; salmeterolxinafoaat 36,3 µg - eq. salmeterol 25 µg - inhalatiepoeder in harde capsule - 120 µg - 20 µg - budesonide 150 µg; salmeterolxinafoaat 36.3 µg - salmeterol and budesonide

België - Nederlands - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

laboratoires s.m.b. sa-nv - budesonide 300 µg; salmeterolxinafoaat 36,3 µg - eq. salmeterol 25 µg - inhalatiepoeder in harde capsule - 240 µg - 20 µg - budesonide 300 µg; salmeterolxinafoaat 36.3 µg - salmeterol and budesonide

Europese Unie - Nederlands - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol fumarate dihydrate - pulmonary disease, chronic obstructive; asthma - geneesmiddelen voor obstructieve aandoeningen van de luchtwegen, - 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).

Europese Unie - Nederlands - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol fumarate dihydrate - pulmonary disease, chronic obstructive; asthma - geneesmiddelen voor obstructieve aandoeningen van de luchtwegen, - 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).

Europese Unie - Nederlands - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a. - beclometasone dipropionate, formoterol-fumaraat-dihydraat, glycopyrronium bromide - longaandoening, chronisch obstructief - geneesmiddelen voor obstructieve aandoeningen van de luchtwegen, - maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and high dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year. copdmaintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (copd) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or a combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist (for effects on symptoms control and prevention of exacerbations see section 5. asthmamaintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and medium dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

medcor pharmaceuticals b.v. artemisweg 232 8239 de lelystad - beclometasondipropionaat 0-water ; formoterolfumaraat 2-water samenstelling overeenkomend met ; formoterol - aërosol, oplossing - ethanol ; norfluraan ; zoutzuur (e 507), - formoterol and beclometasone

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

dr. fisher farma b.v. schutweg 23 8243 pc lelystad - beclometasondipropionaat 0-water ; formoterolfumaraat 2-water - aërosol, oplossing - ethanol ; norfluraan ; zoutzuur (e 507), - formoterol and beclometasone

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

medcor pharmaceuticals b.v. artemisweg 232 8239 de lelystad - beclometasondipropionaat 0-water 100 µg/dosis ; formoterolfumaraat 2-water 6 µg/dosis samenstelling overeenkomend met ; formoterol 4,9 µg/dosis - aërosol, oplossing - ethanol 7 mg/dosis ; norfluraan ; zoutzuur (e 507), - formoterol and beclometasone

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

dr. fisher farma b.v. - beclometasondipropionaat 0-water ; formoterolfumaraat 2-water samenstelling overeenkomend met ; formoterol - aërosol, oplossing - ethanol ; norfluraan ; zoutzuur (e 507), - formoterol and beclometasone