United States - English - NLM (National Library of Medicine)

padagis us llc - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 3 mg - entocort ec is 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. entocort ec is 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. entocort ec is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of entocort ec. 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 reproduction studies with pregnant rats and rabbits, administration of subcutaneous budesonide during organogenesis at doses approximately 0.5 times or 0.05 times, respecti

Australia - English - Department of Health (Therapeutic Goods Administration)

astrazeneca pty ltd - budesonide, quantity: 80 microgram; formoterol fumarate dihydrate, quantity: 4.5 microgram - inhalation, pressurised - excipient ingredients: povidone; macrogol 1000; apaflurane - asthma symbicort rapihaler 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 (see section 4.2 dose and method of administration). chronic obstructive pulmonary disease (copd) symbicort 200/6 is indicated for the symptomatic treatment of moderate to severe copd (fev1 < or = 50% predicted normal) in adults with frequent symptoms despite long-acting bronchodilator use, and/or a history of recurrent exacerbations. symbicort is not indicated for the initiation of bronchodilator therapy in copd.

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - budesonide 80ug;  ;  ;  ; formoterol fumarate 4.5ug;   - aerosol inhaler, metered dose - 100/6 - active: budesonide 80ug       formoterol fumarate 4.5ug   excipient: apaflurane macrogol 1000 povidone - symbicort rapihaler 100/6 is indicated in the regular treatment of asthma where use of a combination (inhaled corticosteroid and long-acting beta2-agonist) is appropriate. this includes: · patients who are not adequately controlled with inhaled corticosteroid therapy and ?as needed? inhaled short-acting beta-2 adrenoceptor agonists. · patients who are already adequately controlled on regular separate long acting beta-agonist and inhaled corticosteroid therapies.

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - budesonide 160ug;  ;  ;  ; formoterol fumarate 4.5ug;   - aerosol inhaler, metered dose - 200/6 - active: budesonide 160ug       formoterol fumarate 4.5ug   excipient: apaflurane macrogol 1000 povidone - symbicort rapihaler 100/6 is indicated in the regular treatment of asthma where use of a combination (inhaled corticosteroid and long-acting beta2-agonist) is appropriate. this includes: · patients who are not adequately controlled with inhaled corticosteroid therapy and ?as needed? inhaled short-acting beta-2 adrenoceptor agonists. · patients who are already adequately controlled on regular separate long acting beta-agonist and inhaled corticosteroid therapies.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

lexon (uk) ltd - budesonide - modified-release capsule - 3mg

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

astrazeneca sdn. bhd. - budesonide; formoterol fumarate dihydrate -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

astrazeneca sdn. bhd. - budesonide; formoterol fumarate dihydrate -

Ireland - English - HPRA (Health Products Regulatory Authority)

astrazeneca uk limited - budesonide - capsules gastro-resistant - 3 milligram

Ireland - English - HPRA (Health Products Regulatory Authority)

imed healthcare ltd. - budesonide; formoterol fumatrate dihydrate - inhalation powder - 100 µg/6 µg/inhalation - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and budesonide

Ireland - English - HPRA (Health Products Regulatory Authority)

imbat limited - budesonide; formoterol fumatrate dihydrate - powder for inhalation - 400mcg/12mcg mcg/dose - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and budesonide