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

golden state medical supply, inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide extended-release tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. budesonide extended-release tablets are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide extended-release tablets. anaphylactic reactions have occurred with other budesonide formulations [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, subcutaneous administration of budesonide during organogenesis at doses 0.5 times and 0.05 times, respectively, the maximum recommended human dose, resulted in increased fetal loss, decreased pup weights, and skeletal abnormalities. maternal toxicity was obs

New Zealand - English - Medsafe (Medicines Safety Authority)

chiesi new zealand limited t/a emerge health - budesonide 3mg - modified release capsule - 3 mg - active: budesonide 3mg excipient: acetyl tributyl citrate ethylcellulose gelatin methacrylic acid - ethyl acrylate copolymer polysorbate 80 purified talc simeticone sugar spheres triethyl citrate - entocort capsules are indicated for the induction of remission in patients with mild to moderate crohn's disease affecting the ileum and/or the ascending colon.

Ireland - English - HPRA (Health Products Regulatory Authority)

dr. falk pharma gmbh - budesonide - gastro-resistant capsule, hard - 3 milligram(s) - corticosteroids acting locally; budesonide

Ireland - English - HPRA (Health Products Regulatory Authority)

tillotts pharma gmbh - budesonide - gastro-resistant capsule, hard - 3 milligram(s) - corticosteroids acting locally; budesonide

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

arrotex pharmaceuticals pty ltd - budesonide, quantity: 0.64 g/l - spray, suspension - excipient ingredients: purified water; glucose monohydrate; disodium edetate; potassium sorbate; hydrochloric acid; polysorbate 80; microcrystalline cellulose; carmellose sodium - for short term (3-6 months) prophylaxis or treatment of seasonal allergic rhinitis in adults and children,aged 12 years and over and perennial allergic rhinitis in adults 18 years and over.

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

arrotex pharmaceuticals pty ltd - budesonide, quantity: 0.64 g/l - spray, suspension - excipient ingredients: purified water; hydrochloric acid; glucose monohydrate; potassium sorbate; disodium edetate; polysorbate 80; microcrystalline cellulose; carmellose sodium - for short term (3-6 months) prophylaxis or treatment of seasonal allergic rhinitis in adults and children,aged 12 years and over and perennial allergic rhinitis in adults 18 years and over.

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

apotex pty ltd - budesonide -

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

apotex pty ltd - budesonide -

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

arrotex pharmaceuticals pty ltd - budesonide, quantity: 0.64 g/l - spray, suspension - excipient ingredients: glucose monohydrate; purified water; disodium edetate; polysorbate 80; hydrochloric acid; potassium sorbate; microcrystalline cellulose; carmellose sodium - for short term (3-6 months) prophylaxis or treatment of seasonal allergic rhinitis in adults and children,aged 12 years and over and perennial allergic rhinitis in adults 18 years and over.

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

apotex pty ltd - budesonide -