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 are 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 an

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

ascend laboratories, llc - febuxostat (unii: 101v0r1n2e) (febuxostat - unii:101v0r1n2e) - febuxostat tablet 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. for the safe and effective use of allopurinol, see allopurinol prescribing information. limitations of use: febuxostat tablet 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,

Malta - English - Medicines Authority

rontis hellas medical and pharmaceutical products s.a. 38, sorou str., athens, maroussi, 15125, greece - febuxostat - film-coated tablet - febuxostat 80 mg - antigout preparations

Malta - English - Medicines Authority

rontis hellas medical and pharmaceutical products s.a. 38, sorou str., athens, maroussi, 15125, greece - febuxostat - film-coated tablet - febuxostat 120 mg - antigout preparations

Malta - English - Medicines Authority

pharos – pharmaceutical oriented services limited lesvou str. (end), thesi loggos, industrial zone, 144 52 metamorfossi attikis,, greece - febuxostat - film-coated tablet - febuxostat 80 mg - antigout preparations

Malta - English - Medicines Authority

pharos – pharmaceutical oriented services limited lesvou str. (end), thesi loggos, industrial zone, 144 52 metamorfossi attikis,, greece - febuxostat - film-coated tablet - febuxostat 120 mg - antigout preparations

Ireland - English - HPRA (Health Products Regulatory Authority)

pinewood laboratories ltd - febuxostat - film-coated tablet - 120 milligram(s) - febuxostat

Ireland - English - HPRA (Health Products Regulatory Authority)

pinewood laboratories ltd - febuxostat - film-coated tablet - 80 milligram(s) - febuxostat

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - febuxostat - film-coated tablet - 120 milligram(s) - febuxostat

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - febuxostat - film-coated tablet - 80 milligram(s) - febuxostat