Europese Unie - Engels - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol - asthma - drugs for obstructive airway diseases, - budesonide/formoterol teva pharma b.v. is indicated in adults 18 years of age and older only.asthmabudesonide/formoterol teva pharma b.v. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: orin patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists. 

Israël - Engels - 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

Israël - Engels - Ministry of Health

astrazeneca (israel) ltd - budesonide micronized; formoterol fumarate - powder for inhalation - budesonide micronized 160 mcg/dose; formoterol fumarate 4.5 mcg/dose - formoterol and budesonide - formoterol and other drugs for obstructive airway diseases - asthmasymbicort turbuhaler 160/4.5 mcg/dose is indicated in adults and adolescents (12 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.chronic obstructive pulmonary disease (copd)symbicort turbuhaler 160/4.5 mcg/dose 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) < 70% predicted normal (post-bronchodilator) and an exacerbation history despite regular bronchodilator therapy.

Filipijnen - Engels - FDA (Food And Drug Administration)

lloyd labs inc - formoterol fumarate - tablet - 40mcg

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

viatris healthcare sa-nv - formoterol fumarate dihydrate 0,006 µg - inhalation powder - 6 µg - formoterol fumarate dihydrate 6 µg - formoterol

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

viatris healthcare sa-nv - formoterol fumarate dihydrate 0,012 µg - inhalation powder - 12 µg - formoterol fumarate dihydrate 12 µg - formoterol

Verenigde Staten - Engels - NLM (National Library of Medicine)

merck sharp & dohme corp. - mometasone furoate (unii: 04201gdn4r) (mometasone - unii:8hr4qj6dw8), formoterol fumarate (unii: w34shf8j2k) (formoterol - unii:5zz84gcw8b) - mometasone furoate 100 ug - dulera is indicated for the twice-daily treatment of asthma in patients 5 years of age and older. dulera should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ics) or whose disease warrants initiation of treatment with both an ics and long-acting beta2 -adrenergic agonist (laba). important limitation of use: - dulera is not indicated for the relief of acute bronchospasm. dulera is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. dulera is contraindicated in patients with known hypersensitivity to mometasone furoate, formoterol fumarate, or any of the ingredients in dulera [see warnings and precautions (5.10)] . risk summary there are no randomized clinical studies of dulera, mometasone furoate, or formoterol fumarate in pregnant women. there are clinical considerations with the use of dulera in pregnant women [see clinical considerations] . animal

Malta - Engels - Medicines Authority

orion corporation orionintie 1, fi-02200 espoo, finland - formoterol fumarate, dihydrate, budesonide - inhalation powder - formoterol fumarate dihydrate 4.5 µg budesonide 160 µg - drugs for obstructive airway diseases

Verenigde Staten - Engels - NLM (National Library of Medicine)

astrazeneca pharmaceuticals lp - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x), formoterol fumarate (unii: w34shf8j2k) (formoterol - unii:5zz84gcw8b) - budesonide 160 ug - symbicort is indicated for the treatment of asthma in patients 6 years of age and older. symbicort should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ics) or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long-acting beta2-adrenergic agonist (laba). important limitations of use: symbicort 160/4.5 is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (copd) including chronic bronchitis and/or emphysema. symbicort 160/4.5 is also indicated to reduce exacerbations of copd. symbicort 160/4.5 is the only strength indicated for the treatment of copd. important limitations of use: the use of symbicort is contraindicated in the following conditions: risk summary there are no adequate and well-controlled studies of symbicort or one of its individual components, formoterol fumarate, in pregnant women; however studies are available for t

Verenigde Staten - Engels - NLM (National Library of Medicine)

organon llc - mometasone furoate (unii: 04201gdn4r) (mometasone - unii:8hr4qj6dw8), formoterol fumarate (unii: w34shf8j2k) (formoterol - unii:5zz84gcw8b) - dulera is indicated for the twice-daily treatment of asthma in patients 5 years of age and older. dulera should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ics) or whose disease warrants initiation of treatment with both an ics and long-acting beta2 -adrenergic agonist (laba). important limitation of use: - dulera is not indicated for the relief of acute bronchospasm. dulera is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. dulera is contraindicated in patients with known hypersensitivity to mometasone furoate, formoterol fumarate, or any of the ingredients in dulera [see warnings and precautions (5.10)] . risk summary there are no randomized clinical studies of dulera, mometasone furoate, or formoterol fumarate in pregnant women. there are clinical considerations with the use of dulera in pregnant women [see clinical considerations] . animal