Ireland - English - HPRA (Health Products Regulatory Authority)

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

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

arrow generics ltd - budesonide - nebuliser liquid - 250microgram/1ml

Canada - English - Health Canada

tillotts pharma gmbh - budesonide - capsule (sustained-release) - 3mg - budesonide 3mg - adrenals

New Zealand - English - Medsafe (Medicines Safety Authority)

te arai biofarma limited - budesonide 3mg - modified release capsule - 3 mg - active: budesonide 3mg excipient: gelatin   ethylcellulose dispersion type b ink black 10a2 iron oxide black iron oxide red methacrylic acid copolymer polysorbate 80 purified talc sugar spheres titanium dioxide   triethyl citrate - 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)

prometheus laboratories 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)

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)

physicians total care, inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 32 ug - rhinocort aqua nasal spray is indicated for the treatment of nasal symptoms of seasonal or perennial allergic rhinitis in adults and children six years of age and older. rhinocort aqua nasal spray is contraindicated in patients with hypersensitivity to any of its ingredients [see warnings and precautions (5.2) ]. teratogenic effects: pregnancy category b. the impact of budesonide on human pregnancy outcomes has been evaluated through assessments of birth registries linked with maternal usage of inhaled budesonide (i.e., pulmicort turbuhaler) and intranasally administered budesonide (i.e., rhinocort aqua nasal spray). the results from population-based prospective cohort epidemiological studies reviewing data from three swedish registries covering approximately 99% of the pregnancies from 1995- 2001 (i.e., swedish medical birth registry; registry of congenital malformations; child cardiology registry) indicate no increased risk for overall congenital malformations from the use of inhaled or intranasal budeso

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

salix pharmaceuticals, inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 28 mg - uceris rectal foam is indicated for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge. uceris rectal foam is contraindicated in patients with a history of a known hypersensitivity to budesonide or any of the ingredients of uceris rectal foam. reactions have included anaphylaxis [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 1.2 times and 0.12 times, respectively, the human intrarectal dose of 4 mg/day, resulted in increased fetal loss, decreased pup weights, and skeletal abnormalities. maternal toxicity was observed in both rats and rabbits at the

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

santarus inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 9 mg - uceris® extended-release tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. uceris is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of uceris. 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 observed in both rats and rabbits at these dose levels (see data ). based on animal da

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

ax pharmaceutical corp - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) -