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

orion corp. - budesonide 320 µg/dosis; formoterolfumaraatdihydraat 9 µg/dosis - inhalatiepoeder - 320 µg/dose - 9 µg/dose - budesonide 320 µg/dosis; formoterolfumaraatdihydraat 9 µg/dosis - formoterol and budesonide

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

orion corp. - budesonide 80 µg/dosis; formoterolfumaraatdihydraat 4,5 µg/dosis - inhalatiepoeder - 80 µg/dose - 4,5 µg/dose - budesonide 80 µg/dosis; formoterolfumaraatdihydraat 4.5 µg/dosis - formoterol and budesonide

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

astrazeneca sa-nv - budesonide, gemicroniseerd 160 µg/dosis; formoterolfumaraatdihydraat 4,5 µg/dosis - aërosol, suspensie - 160 µg/dose - 4,5 µg/dose - budesonide 160 µg/dosis; formoterolfumaraatdihydraat 4.5 µg/dosis - formoterol 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).

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

orion corporation orionintie 1 sf-02200 espoo (finland) - budesonide 160 µg/dosis ; formoterolfumaraat 2-water 4,5 µg/dosis samenstelling overeenkomend met ; formoterol 3,7 µg/dosis - inhalatiepoeder - lactose 1-water, - formoterol and budesonide

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

euro registratie collectief b.v. - fluticasonpropionaat ; formoterolfumaraat 2-water samenstelling overeenkomend met ; formoterol - aërosol, suspensie - dinatriumcromoglicaat ; ethanol ; heptafluoropropaan, - formoterol and budesonide

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

astrazeneca b.v prinses beatrixlaan 582 2595 bm den haag - budesonide 200 µg/dosis ; formoterolfumaraat 2-water 6 µg/dosis samenstelling overeenkomend met ; formoterol 4,9 µg/dosis - inhalatiepoeder - lactose 1-water, - formoterol and budesonide

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

delphi pharmaceuticals b.v. spoorhaven 39 2651 av berkel en rodenrijs - budesonide ; formoterolfumaraat 2-water samenstelling overeenkomend met ; formoterol - inhalatiepoeder - lactose 1-water, - formoterol and budesonide

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

medcor pharmaceuticals b.v. artemisweg 232 8239 de lelystad - budesonide ; formoterolfumaraat 2-water samenstelling overeenkomend met ; formoterol - inhalatiepoeder - lactose 1-water, - formoterol and budesonide