Ireland - English - HPRA (Health Products Regulatory Authority)

rowa pharmaceuticals limited - febuxostat - film-coated tablet - 80 milligram(s) - preparations inhibiting uric acid production; febuxostat

Canada - English - Health Canada

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

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.

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

a menarini australia pty ltd - febuxostat, quantity: 80 mg - tablet - excipient ingredients: microcrystalline cellulose; hyprolose; croscarmellose sodium; magnesium stearate; silicon dioxide; lactose monohydrate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - treatment of chronic symptomatic hyperuricaemia in conditions where urate deposition has already occurred (gouty arthritis and/or tophus formation) in adults with gout.

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

mylan pharmaceuticals inc. - 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)] . limited available data with febuxostat tablet 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

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

alembic pharmaceuticals 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

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

alembic pharmaceuticals limited - 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 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 expos

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

sun pharmaceutical industries, 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 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). no advers