Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

tillotts pharma gmbh - budesonide, micronised 2,3 mg/ml - tablet for rectal suspension - 2,3 mg - budesonide 2.3 mg - budesonide

Malta - English - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - rectal suspension - budesonide 2.3 mg - antidiarrheals, intestinal antiinflammatory/antiinfective agents

Malta - English - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - budesonide - dispersible tablet, rectal suspension - budesonide 0.02 milligram(s)/millilitre - antidiarrheals, intestinal antiinflammatory/antiinfective agents

Malta - English - Medicines Authority

tillotts pharma uk ltd wellingore hall, wellingore lincolnshire, ln5 0hx, united kingdom - budesonide - dispersible tablet rectal suspension - budesonide 0.2 mg/ml - antidiarrheals, intestinal antiinflammatory/antiinfective agents

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

tillotts pharma uk ltd - budesonide - enema - 20microgram/1ml

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.

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

physicians total care, inc. - 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 iluem and/or the ascending colon and - 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. 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. entocort ec is contraindicated in patients with known hypersensitivity to budesonide.

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

Canada - English - Health Canada

tillotts pharma gmbh - budesonide - enema - 2.3mg - budesonide 2.3mg - anti-inflammatory agents

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

chiesi australia pty ltd - budesonide, quantity: 3 mg - capsule, modified release - excipient ingredients: sodium lauryl sulfate; iron oxide yellow; tributyl acetylcitrate; colloidal anhydrous silica; titanium dioxide; liquid paraffin; dimeticone 1000; purified talc; iron oxide black; ethylcellulose; gelatin; triethyl citrate; methacrylic acid copolymer; iron oxide red; polysorbate 80; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; potassium hydroxide; maize starch; sucrose - the induction of remission in adult patients with mild to moderate crohn's disease affecting the ileum and/or the ascending colon.