Canada - English - Health Canada

sanis health inc - febuxostat (febuxostat hemihydrate) - tablet - 80mg - febuxostat (febuxostat hemihydrate) 80mg

New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - febuxostat 120mg (as febuxostat hemihydrate) - film coated tablet - 120 mg - active: febuxostat 120mg (as febuxostat hemihydrate) excipient: colloidal silicon dioxide croscarmellose sodium hyprolose lactose monohydrate magnesium stearate microcrystalline cellulose opadry yellow 85f32645 purified water - treatment of chronic hyperuricaemia in patients with gout (including a history, or presence of, tophus and/or gouty arthritis). febuxostat is indicated in adults.

New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - febuxostat 80mg (as febuxostat hemihydrate) - film coated tablet - 80 mg - active: febuxostat 80mg (as febuxostat hemihydrate) excipient: colloidal silicon dioxide croscarmellose sodium hyprolose lactose monohydrate magnesium stearate microcrystalline cellulose opadry yellow 85f32645 purified water - treatment of chronic hyperuricaemia in patients with gout (including a history, or presence of, tophus and/or gouty arthritis). febuxostat is indicated in adults.

Canada - English - Health Canada

teva canada limited - febuxostat (febuxostat hemihydrate) - tablet - 80mg - febuxostat (febuxostat hemihydrate) 80mg - antigout agents

Canada - English - Health Canada

marcan pharmaceuticals inc - febuxostat (febuxostat hemihydrate) - tablet - 80mg - febuxostat (febuxostat hemihydrate) 80mg - antigout agents

Canada - English - Health Canada

auro pharma inc - febuxostat (febuxostat hemihydrate) - tablet - 80mg - febuxostat (febuxostat hemihydrate) 80mg

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

aphena pharma solutions - tennessee, llc - febuxostat (unii: 101v0r1n2e) (febuxostat - unii:101v0r1n2e) - febuxostat tablets are a xanthine oxidase (xo) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. for the safe and effective use of allopurinol, see allopurinol prescribing information. limitations of use: febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. febuxostat tablets are contraindicated in patients being treated with azathioprine or mercaptopurine [see drug interactions (7)] . risk summary: limited available data with febuxostat use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. no adverse developmental effects were observed in embryo-fetal development studies with oral administration of febuxostat to pregnant rats and rabbits during organogenesis at doses that p

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

aphena pharma solutions - tennessee, llc - febuxostat (unii: 101v0r1n2e) (febuxostat - unii:101v0r1n2e) - febuxostat tablets are a xanthine oxidase (xo) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. for the safe and effective use of allopurinol, see allopurinol prescribing information. limitations of use: febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. febuxostat tablets are contraindicated in patients being treated with azathioprine or mercaptopurine [see drug interactions (7)] . risk summary: limited available data with febuxostat use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. no adverse developmental effects were observed in embryo-fetal development studies with oral administration of febuxostat to pregnant rats and rabbits during organogenesis at doses that produced maternal exposures up to 40 and 51

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

tris pharma inc - febuxostat (unii: 101v0r1n2e) (febuxostat - unii:101v0r1n2e) - febuxostat tablets are xanthine oxidase (xo) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. limitations of use : febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. febuxostat tablets are contraindicated in patients being treated with azathioprine or mercaptopurine [see drug interactions (7)] . risk summary limited available data with febuxostat tablets use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. no adverse developmental effects were observed in embryo-fetal development studies with oral administration of febuxostat to pregnant rats and rabbits during organogenesis at doses that produced maternal exposures up to 40 and 51 times, respectively, the exposure at the maximum recommended human dose (mrhd). n

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

aphena pharma solutions - tennessee, llc - febuxostat (unii: 101v0r1n2e) (febuxostat - unii:101v0r1n2e) - febuxostat tablets are xanthine oxidase (xo) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. for the safe and effective use of allopurinol, see allopurinol prescribing information. limitations of use : febuxostat tablets is not recommended for the treatment of asymptomatic hyperuricemia. febuxostat tablets are contraindicated in patients being treated with azathioprine or mercaptopurine [see drug interactions (7)] . risk summary limited available data with febuxostat tablets use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. no adverse developmental effects were observed in embryo-fetal development studies with oral administration of febuxostat to pregnant rats and rabbits during organogenesis at doses that produced maternal exposures up to 40 a