האיחוד האירופי - אנגלית - EMA (European Medicines Agency)

teva pharma b.v.  - budesonide, formoterol fumarate dihydrate - asthma; pulmonary disease, chronic obstructive - 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:-in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.or-in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.copdsymptomatic treatment of patients with copd with forced expiratory volume in 1 second (fev1) 

מלטה - אנגלית - Malta Medicines Authority

teva pharma b.v. (utrecht) swensweg 5, 2031 ga haarlem, netherlands - budesonide - nebuliser suspension - budesonide 0.25 mg/ml - drugs for obstructive airway diseases

אירלנד - אנגלית - HPRA (Health Products Regulatory Authority)

pco manufacturing ltd. - formoterol fumatrate dihydrate; budesonide - inhalation powder - 400/12 microgram(s)/dose - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and budesonide

אירלנד - אנגלית - HPRA (Health Products Regulatory Authority)

astrazeneca uk limited - budesonide - powder for inhalation - 400 mcg/acutuation - budesonide

מלטה - אנגלית - Malta Medicines Authority

astrazeneca ab se-151 85, södertälje, sweden - formoterol, budesonide - inhalation powder - formoterol 12 µg budesonide 400 µg - drugs for obstructive airway diseases

אירלנד - אנגלית - HPRA (Health Products Regulatory Authority)

teva pharma b.v. - budesonide - nebuliser suspension - 0.25 mg/2ml - glucocorticoids

ארצות הברית - אנגלית - NLM (National Library of Medicine)

american health packaging - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide delayed-release capsules (enteric coated) are indicated for the treatment of mild to moderate active crohn's disease involving the ileum and/or the ascending colon in patients 8 years of age and older. budesonide delayed-release capsules (enteric coated) are indicated for the maintenance of clinical remission of mild to moderate crohn's disease involving the ileum and/or the ascending colon for up to 3 months in adults. budesonide capsules (enteric coated) are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide capsules (enteric coated). serious hypersensitivity reactions, including anaphylaxis have occurred [see adverse reactions (6.2)]. risk summary limited published studies report on the use of budesonide in pregnant women; however, the data are insufficient to inform a drug-associated risk for major birth defects and miscarriage. there are clinical considerations [see clinical considerations]. in animal re

ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

viatris limited - budesonide 6.5%{relative} - powder for inhalation - 400 mcg - active: budesonide 6.5%{relative} excipient: lactose monohydrate

אירלנד - אנגלית - HPRA (Health Products Regulatory Authority)

teva pharma b.v. - budesonide - nebuliser suspension - 0.5 mg/2ml

ארצות הברית - אנגלית - NLM (National Library of Medicine)

astrazeneca pharmaceuticals lp - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 180 ug - pulmicort flexhaler is indicated for the maintenance treatment of asthma as prophylactic therapy in patients six years of age or older. limitations of use: the use of pulmicort flexhaler is contraindicated in the following conditions: risk summary there are no adequate well-controlled studies of pulmicort flexhaler in pregnant women. however, there are published studies on the use of budesonide, the active ingredient in pulmicort flexhaler, in pregnant women. in animal reproduction studies, budesonide, administered by the subcutaneous route, caused structural abnormalities, was embryocidal, and reduced fetal weights in rats and rabbits at less than the maximum recommended human daily inhalation dose (mrhdid), but these effects were not seen in rats that received inhaled doses approximately 2 times the mrhdid (see data ). studies of pregnant women have not shown that inhaled budesonide increases the risk of abnormalities when administered during pregnancy. experience with oral corticosteroids suggests that rod