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

arrotex pharmaceuticals pty ltd - mycophenolate mofetil, quantity: 500 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; hyprolose; povidone; purified talc; magnesium stearate; titanium dioxide; hypromellose; iron oxide red; iron oxide black; macrogol 400; indigo carmine aluminium lake - prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. prophylaxis of organ rejection in paediatric patients (with a body surface area > 1.5 m2) receiving allogeneic renal transplants.

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

sandoz pty ltd - mycophenolate mofetil, quantity: 500 mg - tablet, film coated - excipient ingredients: hyprolose; hypromellose; povidone; purified talc; titanium dioxide; croscarmellose sodium; macrogol 400; iron oxide red; iron oxide black; microcrystalline cellulose; magnesium stearate - mycophenolate sandoz is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. . mycophenolate sandoz is indicated for the prophylaxis of organ rejection in paediatric patients (6 to 18 years) receiving allogeneic renal transplants.

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

alphapharm pty ltd - azathioprine, quantity: 50 mg - tablet, film coated - excipient ingredients: lactose monohydrate; pregelatinised maize starch; magnesium stearate; maize starch; macrogol 400; stearic acid; hypromellose - indicatins as at 2 febuary 2005 : thioprine is used as an immunosuppressant antimetabolite either alone, or more commonly in combination with other agents (usually corticosteroids) and procedures which influence the immune response. therapeutic effect may be evident only after weeks or months and can include a steroid-sparing effect, thereby reducing the toxicity associated with high dosage and prolonged usage of corticosteroids. thioprine, in combination with corticosteroids and/or other immunosuppressive agents and procedures, is indicated in the management of patients receiving organ transplants. thioprine, either alone or more usually in combination with corticosteroids and/or other procedures, has been used with clinical benefit which may include reduction of dosage or discontinuation of corticosteroids, in a proportion of patients suffering from the following; severe rheumatoid arthritis; systemic lupus erythematosus; dermatomyositis/polymyositis; autoimmune chronic active hepatitis; pemphigus vulgaris

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

novartis pharmaceuticals australia pty ltd - imatinib, quantity: 400 mg (equivalent: imatinib mesilate, qty 478 mg) - tablet, film coated - excipient ingredients: colloidal anhydrous silica; crospovidone; microcrystalline cellulose; hypromellose; magnesium stearate; purified talc; iron oxide red; macrogol 4000; iron oxide yellow - glivec is indicated for the: -treatment of patients with chronic myeloid leukaemia (cml). -treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. -treatment of adult patients with relapsed or refractory ph+ all as monotherapy. -treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements, where conventional therapies have failed. -treatment of adult patients with aggressive systemic mastocytosis (asm) where conventional therapies have failed. treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). -treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) -adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist (see dosage and administration and clinical trials) . -treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp)

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

novartis pharmaceuticals australia pty ltd - imatinib, quantity: 100 mg (equivalent: imatinib mesilate, qty 119.5 mg) - tablet, film coated - excipient ingredients: crospovidone; hypromellose; colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; purified talc; iron oxide yellow; macrogol 4000; iron oxide red - glivec is indicated for the: -treatment of patients with chronic myeloid leukaemia (cml). -treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. -treatment of adult patients with relapsed or refractory ph+ all as monotherapy. -treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements, where conventional therapies have failed. -treatment of adult patients with aggressive systemic mastocytosis (asm) where conventional therapies have failed. treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). -treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) -adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist (see dosage and administration and clinical trials) . -treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp) glivec is indicated for the: -treatment of patients with chronic myeloid leukaemia (cml). -treatment of adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. -treatment of adult patients with relapsed or refractory ph+ all as monotherapy. -treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements, where conventional therapies have failed. -treatment of adult patients with aggressive systemic mastocytosis (asm) where conventional therapies have failed. treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). -treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) -adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist (see dosage and administration and clinical trials). -treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

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

pfizer australia pty ltd - cabergoline, quantity: 0.5 mg - tablet, uncoated - excipient ingredients: leucine; lactose - indications as at 10 june 2004 : inhibition of physiological lactation - dostinex is indicated for the prevention of the onset of physiological lactation in the puerperium for clearly defined medical reasons. treatment of hyperprolactinemic disorders - dostinex is indicated for the treatment of pathological hyperprolactinaemia.

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

arrotex pharmaceuticals pty ltd - azathioprine, quantity: 50 mg - tablet - excipient ingredients: lactose monohydrate; magnesium stearate; maize starch; microcrystalline cellulose; macrogol 8000; hypromellose; macrogol 400 - azathioprine is used as an immunosuppressant anti-metabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and procedures which influence the immune response. therapeutic effects may be evident only after weeks or months and can include a steroid-sparing effect, thereby reducing the toxicity associated with high dosage and prolonged usage of corticosteroids.,azathioprine, in combination with corticosteroids and/or other immunosuppressive agents and procedures, is indicated in the management of patients receiving organ transplants.,azathioprine, either alone or more usually in combination with corticosteroids and/or other procedures, has been used with clinical benefit which may include reduction of dosage or discontinuation of corticosteroids, in a proportion of patients suffering from the following: ,? severe rheumatoid arthritis;,? systemic lupus erythematosus;,? dermatomyositis / polymyositis;,? autoimmune chronic active hepatitis;,? pemphigus vulgaris;,? polyarteritis nodosa;,? autoimmune haemolytic anaemia; ,? chronic refractory idiopathic thrombocytopenic purpura.

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

arrotex pharmaceuticals pty ltd - azathioprine, quantity: 25 mg - tablet - excipient ingredients: maize starch; lactose monohydrate; magnesium stearate; microcrystalline cellulose; titanium dioxide; hypromellose; iron oxide yellow; iron oxide red; macrogol 400 - azathioprine is used as an immunosuppressant anti-metabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and procedures which influence the immune response. therapeutic effects may be evident only after weeks or months and can include a steroid-sparing effect, thereby reducing the toxicity associated with high dosage and prolonged usage of corticosteroids.,azathioprine, in combination with corticosteroids and/or other immunosuppressive agents and procedures, is indicated in the management of patients receiving organ transplants.,azathioprine, either alone or more usually in combination with corticosteroids and/or other procedures, has been used with clinical benefit which may include reduction of dosage or discontinuation of corticosteroids, in a proportion of patients suffering from the following: ,? severe rheumatoid arthritis;,? systemic lupus erythematosus;,? dermatomyositis / polymyositis;,? autoimmune chronic active hepatitis;,? pemphigus vulgaris;,? polyarteritis nodosa;,? autoimmune haemolytic anaemia; ,? chronic refractory idiopathic thrombocytopenic purpura.

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

lupin australia pty limited - zolpidem tartrate, quantity: 10 mg - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; sodium starch glycollate type a; hypromellose; magnesium stearate; titanium dioxide; macrogol 400 - zolpidem tartrate is indicated for the short term treatment of insomnia in adults (see dosage and administration).

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

pharmacor pty ltd - zolpidem tartrate, quantity: 10 mg - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; sodium starch glycollate; hypromellose; magnesium stearate; titanium dioxide; macrogol 400 - short-term treatment of insomnia in adults.