Irsko - angličtina - HPRA (Health Products Regulatory Authority)

imed healthcare ltd. - formoterol fumarate dihydrate; budesonide - inhalation powder - 400 µg /12 µg/inhalation - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and budesonide - 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 where use of a combination is appropriate; in adults, aged 18 years and older, for the symptomatic treatment of patients with severe copd and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators

Polsko - polština - URPL (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych)

astrazeneca ab - budesonidum + formoteroli fumaras - proszek do inhalacji - (80 mcg + 4,5 mcg)/dawkę inh.

Polsko - polština - URPL (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych)

astrazeneca ab - budesonidum + formoteroli fumaras - proszek do inhalacji - (160 mcg + 4,5 mcg)/dawkę inh.

Polsko - polština - URPL (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych)

astrazeneca ab - budesonidum + formoteroli fumaras - proszek do inhalacji - (320 mcg + 9 mcg)/dawkę inh.

Nový Zéland - angličtina - Medsafe (Medicines Safety Authority)

astrazeneca limited - budesonide 320ug equivalent to 400 µg metered dose;  ;  ;  ; formoterol fumarate 9ug equivalent to 12 µg metered dose;   - powder for inhalation - active: budesonide 320ug equivalent to 400 µg metered dose       formoterol fumarate 9ug equivalent to 12 µg metered dose   excipient: lactose monohydrate - symbicort turbuhaler is indicated in the treatment of asthma to achieve overall asthma control, including the prevention and relief of symptoms as well as the reduction of the risk of exacerbations. symbicort turbuhaler is suitable for any asthma severity, where the use of inhaled corticosteroids is appropriate.

Izrael - angličtina - Ministry of Health

astrazeneca (israel) ltd - budesonide micronized; formoterol fumarate - powder for inhalation - budesonide micronized 320 mcg/dose; formoterol fumarate 9 mcg/dose - formoterol and budesonide - formoterol and other drugs for obstructive airway diseases - symbicort turbuhaler 320/9 mcg/dose is indicated in adults and adolescents, age 12 -17 for the regular treatment of asthma where use of a combination (inhaled corticosteroid and long acting β2 adrenoceptor-agonist) is appropriate:-patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short acting β2 adrenoceptor-agonists.or- patients already adequately controlled on both inhaled corticosteroids and long acting β2 adrenoceptoragonists.chronic obstructive pulmonary disease (copd)symbicort turbuhaler 320/9 mcg/dose is indicated in adults, aged 18 years and older, for the symptomatic treatment of patients with copd with forced expiratory volume in i second (fev1) < 70% predicted normal (post-bronchodilator) and an exacerbation history despite regular bronchodilator therapy

Nizozemsko - nizozemština - 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

Nizozemsko - nizozemština - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

dr. fisher farma b.v. schutweg 23 8243 pc lelystad - budesonide ; formoterolfumaraat 2-water samenstelling overeenkomend met ; formoterol - inhalatiepoeder - lactose 1-water, - formoterol and budesonide

Nizozemsko - nizozemština - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

euro registratie collectief b.v. - budesonide ; formoterolfumaraat 2-water samenstelling overeenkomend met ; formoterol - inhalatiepoeder - lactose 1-water - formoterol and budesonide

Švédsko - švédština - Läkemedelsverket (Medical Products Agency)

astrazeneca ab - budesonid; formoterolfumaratdihydrat - inhalationspulver - 160 mikrogram/4,5 mikrogram/inhalation - formoterolfumaratdihydrat 4,5 mikrog aktiv substans; laktosmonohydrat hjälpämne; budesonid 160 mikrog aktiv substans - formoterol och budesonid