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

macleods pharmaceuticals limited - febuxostat (unii: 101v0r1n2e) (febuxostat - unii:101v0r1n2e) - febuxostat is 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. limitations of use: febuxostat is not recommended for the treatment of asymptomatic hyperuricemia. febuxostat is 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 adverse development

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

laboratoires s.m.b. sa-nv - febuxostat hemihydrate 82,24 mg - eq. febuxostat 80 mg - coated tablet - 80 mg - febuxostat hemihydrate 82.24 mg - febuxostat

Canada - English - Health Canada

jamp pharma corporation - febuxostat - tablet - 80mg - febuxostat 80mg - antigout agents

Malta - English - Medicines Authority

actavis group ptc ehf revkjavikurvegi 76-78, 220 hafnarfjordur, iceland - febuxostat - film-coated tablet - febuxostat 80 mg - antigout preparations

Malta - English - Medicines Authority

meditop pharmaceutical ltd. pilisborosjeno, ady endre utca 1., 2097,, hungary - febuxostat - film-coated tablet - febuxostat 80 mg - antigout preparations

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

nucare 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. febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia.   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 is contraindicated in patients being treated with azathioprine or merca

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

rebel distributors corp - febuxostat (unii: 101v0r1n2e) (febuxostat - unii:101v0r1n2e) - febuxostat 80 mg - uloric® is a xanthine oxidase (xo) inhibitor indicated for the chronic management of hyperuricemia in patients with gout. uloric is not recommended for the treatment of asymptomatic hyperuricemia. uloric is contraindicated in patients being treated with azathioprine, mercaptopurine, or theophylline [see drug interactions (7)] . pregnancy category c : there are no adequate and well-controlled studies in pregnant women. uloric should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. febuxostat was not teratogenic in rats and rabbits at oral doses up to 48 mg per kg (40 and 51 times the human plasma exposure at 80 mg per day for equal body surface area, respectively) during organogenesis. however, increased neonatal mortality and a reduction in the neonatal body weight gain were observed when pregnant rats were treated with oral doses up to 48 mg per kg (40 times the human plasma exposure at 80 mg per day) during organogenesis and through lactation period. febuxos

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

colorama pharmaceuticals ltd - febuxostat - tablet - 80mg

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

de pharmaceuticals - febuxostat - tablet - 80mg

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