European Union - English - EMA (European Medicines Agency)

mylan pharmaceuticals limited - febuxostat - hyperuricemia; arthritis, gouty; gout - antigout preparations - febuxostat mylan is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of tumor lysis syndrome (tls).febuxostat mylan is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).febuxostat mylan is indicated in adults.

European Union - English - EMA (European Medicines Agency)

krka, d.d., novo mesto - febuxostat - hyperuricemia; gout - antigout preparations - febuxostat krka is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).febuxostat krka is indicated in adults.

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

arrotex pharmaceuticals pty ltd - allopurinol, quantity: 300 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; maize starch; povidone; sodium starch glycollate; stearic acid - indications as at 6 february 2003: main clinical manifestations of urate/uric acid deposition. these are gouty arthritis, skin tophi and/or renal involvement through crystal deposition or stone formation. such clinical manifestations may occur in: idiopathic gout; uric acid lithiasis; acute uric acid nephropathy; neoplastic disease and myeloproliferative disease with high cell turnover rates, in which high urate levels occur either spontaneously or after cytotoxic therapy, certain enzyme disorders which lead to overproduction of urate and involve: hypoxanthine guanine phosphoriboslytransferase including lesch-nyhan syndrome, glucose 6-phosphatase including glycogen storage disease, phosphoribosylpyrophosphate synthetase, phosphoribosylpyrophosphate amidotransferase. allopurinol-str is indicated for the management of 2,8-dihydroxyadenine (2,8-dha) renal stones related to deficient activity of adenine phosphoribosyl transferase. allopurinol-str is indicated for the management of recurred mixed calcium oxalate renal stones in the presence of hyperuricosuria, when fluid, dietary and similar measures have failed.

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

arrotex pharmaceuticals pty ltd - allopurinol, quantity: 100 mg - tablet, uncoated - excipient ingredients: maize starch; lactose monohydrate; povidone; stearic acid - indications as at 6 february 2003: main clinical manifestations of urate/uric acid deposition. these are gouty arthritis, skin tophi and/or renal involvement through crystal deposition or stone formation. such clinical manifestations may occur in: idiopathic gout; uric acid lithiasis; acute uric acid nephropathy; neoplastic disease and myeloproliferative disease with high cell turnover rates, in which high urate levels occur either spontaneously or after cytotoxic therapy, certain enzyme disorders which lead to overproduction of urate and involve: hypoxanthine guanine phosphoriboslytransferase including lesch-nyhan syndrome, glucose 6-phosphatase including glycogen storage disease, phosphoribosylpyrophosphate synthetase, phosphoribosylpyrophosphate amidotransferase. allopurinol-str is indicated for the management of 2,8-dihydroxyadenine (2,8-dha) renal stones related to deficient activity of adenine phosphoribosyl transferase. allopurinol-str is indicated for the management of recurred mixed calcium oxalate renal stones in the presence of hyperuricosuria, when fluid, dietary and similar measures have failed.

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

sandoz pty ltd - allopurinol, quantity: 300 mg - tablet, uncoated - excipient ingredients: powdered cellulose; povidone; macrogol 4000; crospovidone; purified talc; magnesium stearate; microcrystalline cellulose - main clinical manifestations of urate/uric acid deposition. these are gouty arthritis, skin tophi and/or renal involvement through crystal deposition or stone formation. such clinical manifestations may occur in: idiopathic gout; uric acid lithiasis; acute uric acid nephropathy; neoplastic disease and myeloproliferative disease with high cell turnover rates, in which high urate levels occur either spontaneously or after cytotoxic therapy; certain enzyme disorders which lead to overproduction of urate and involve hypoxanthine guanine phosphoribosyltransferase including lesch-nyhan syndrome, glucose-6-phosphatase including glycogen storage disease, phosphoribosylpyrophosphate synthetase, phosphoribosylpyrophosphate amidotransferase. management of 2,8-dihydroxyadenine (2,8-dha) renal stones relate to deficient activity of adenine phosphoribosyl transferase. management of recurrent mixed calcium oxalate renal stones in the presence of hyperuricosuria, when fluid, dietary and similar measures have failed.

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

sandoz pty ltd - allopurinol, quantity: 100 mg - tablet, uncoated - excipient ingredients: powdered cellulose; povidone; macrogol 4000; crospovidone; purified talc; magnesium stearate; microcrystalline cellulose - main clinical manifestations of urate/uric acid deposition. these are gouty arthritis, skin tophi and/or renal involvement through crystal deposition or stone formation. such clinical manifestations may occur in: idiopathic gout; uric acid lithiasis; acute uric acid nephropathy; neoplastic disease and myeloproliferative disease with high cell turnover rates, in which high urate levels occur either spontaneously or after cytotoxic therapy; certain enzyme disorders which lead to overproduction of urate and involve hypoxanthine guanine phosphoribosyltransferase including lesch-nyhan syndrome, glucose-6-phosphatase including glycogen storage disease, phosphoribosylpyrophosphate synthetase, phosphoribosylpyrophosphate amidotransferase. management of 2,8-dihydroxyadenine (2,8-dha) renal stones relate to deficient activity of adenine phosphoribosyl transferase. management of recurrent mixed calcium oxalate renal stones in the presence of hyperuricosuria, when fluid, dietary and similar measures have failed.

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

avallon pharmaceuticals pty ltd - allopurinol, quantity: 300 mg - tablet, uncoated - excipient ingredients: powdered cellulose; povidone; macrogol 4000; crospovidone; purified talc; magnesium stearate; microcrystalline cellulose - main clinical manifestations of urate/uric acid deposition. these are gouty arthritis, skin tophi and/or renal involvement through crystal deposition or stone formation. such clinical manifestations may occur in: idiopathic gout; uric acid lithiasis; acute uric acid nephropathy; neoplastic disease and myeloproliferative disease with high cell turnover rates, in which high urate levels occur either spontaneously or after cytotoxic therapy; certain enzyme disorders which lead to overproduction of urate and involve hypoxanthine guanine phosphoribosyltransferase including lesch-nyhan syndrome, glucose-6-phosphatase including glycogen storage disease, phosphoribosylpyrophosphate synthetase, phosphoribosylpyrophosphate amidotransferase. management of 2,8-dihydroxyadenine (2,8-dha) renal stones relate to deficient activity of adenine phosphoribosyl transferase. management of recurrent mixed calcium oxalate renal stones in the presence of hyperuricosuria, when fluid, dietary and similar measures have failed.

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

avallon pharmaceuticals pty ltd - allopurinol, quantity: 100 mg - tablet, uncoated - excipient ingredients: powdered cellulose; povidone; macrogol 4000; crospovidone; purified talc; magnesium stearate; microcrystalline cellulose - main clinical manifestations of urate/uric acid deposition. these are gouty arthritis, skin tophi and/or renal involvement through crystal deposition or stone formation. such clinical manifestations may occur in: idiopathic gout; uric acid lithiasis; acute uric acid nephropathy; neoplastic disease and myeloproliferative disease with high cell turnover rates, in which high urate levels occur either spontaneously or after cytotoxic therapy; certain enzyme disorders which lead to overproduction of urate and involve hypoxanthine guanine phosphoribosyltransferase including lesch-nyhan syndrome, glucose-6-phosphatase including glycogen storage disease, phosphoribosylpyrophosphate synthetase, phosphoribosylpyrophosphate amidotransferase. management of 2,8-dihydroxyadenine (2,8-dha) renal stones relate to deficient activity of adenine phosphoribosyl transferase. management of recurrent mixed calcium oxalate renal stones in the presence of hyperuricosuria, when fluid, dietary and similar measures have failed.

European Union - English - EMA (European Medicines Agency)

schering-plough europe - interferon alfa-2b - hepatitis c, chronic; hepatitis b, chronic - immunostimulants, - chronic hepatitis b: treatment of adult patients with chronic hepatitis b associated with evidence of hepatitis b viral replication (presence of hbv-dna and hbeag), elevated alanine aminotransferase (alt) and histologically proven active liver inflammation and/or fibrosis.chronic hepatitis c:adult patients:introna is indicated for the treatment of adult patients with chronic hepatitis c who have elevated transaminases without liver decompensation and who are positive for serum hcv-rna or anti-hcv (see section 4.4).the best way to use introna in this indication is in combination with ribavirin.chidren and adolescents:introna is intended for use, in a combination regimen with ribavirin, for the treatment of children and adolescents 3 years of age and older, who have chronic hepatitis c, not previously treated, without liver decompensation, and who are positive for serum hcv-rna. the decision to treat should be made on a case by case basis, taking into account any evidence of disease progression such as hepatic inflammation and fibrosis, as well as prognostic factors for response, hcv genotype and viral load. the expected benefit of treatment should be weighed against the safety findings observed for paediatric subjects in the clinical trials (see sections 4.4, 4.8 and 5.1).

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

arrotex pharmaceuticals pty ltd - allopurinol, quantity: 100 mg - tablet, uncoated - excipient ingredients: povidone; maize starch; lactose monohydrate; stearic acid - indications as at 6 february 2003: main clinical manifestations of urate/uric acid deposition. these are gouty arthritis, skin tophi and/or renal involvement through crystal deposition or stone formation. such clinical manifestations may occur in: idiopathic gout; uric acid lithiasis; acute uric acid nephropathy; neoplastic disease and myeloproliferative disease with high cell turnover rates, in which high urate levels occur either spontaneously or after cytotoxic therapy, certain enzyme disorders which lead to overproduction of urate and involve: hypoxanthine guanine phosphoriboslytransferase including lesch-nyhan syndrome, glucose 6-phosphatase including glycogen storage disease, phosphoribosylpyrophosphate synthetase, phosphoribosylpyrophosphate amidotransferase. allopurinol-arx is indicated for the management of 2,8-dihydroxyadenine (2,8-dha) renal stones related to deficient activity of adenine phosphoribosyl transferase. allopurinol-arx is indicated for the management of recurred mixed calcium oxalate renal stones in the presence of hyperuricosuria, when fluid, dietary and similar measures have failed.