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

sun pharma anz pty ltd - imatinib mesilate, quantity: 119.5 mg - tablet, film coated - excipient ingredients: magnesium stearate; hypromellose; purified talc; iron oxide yellow; macrogol 6000; iron oxide red - imatinib rbx 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 - Inggeris - Department of Health (Therapeutic Goods Administration)

sun pharma anz pty ltd - imatinib mesilate, quantity: 119.5 mg - tablet, film coated - excipient ingredients: magnesium stearate; hypromellose; purified talc; iron oxide yellow; macrogol 6000; iron oxide red - imatinib rbx 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 - Inggeris - Department of Health (Therapeutic Goods Administration)

sun pharma anz pty ltd - imatinib mesilate, quantity: 478 mg - tablet, film coated - excipient ingredients: magnesium stearate; hypromellose; purified talc; iron oxide yellow; macrogol 6000; iron oxide red - imatinib rbx 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 - Inggeris - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - infliximab, quantity: 100 mg - injection, powder for - excipient ingredients: dibasic sodium phosphate dihydrate; monobasic sodium phosphate monohydrate; polysorbate 80; sucrose - rheumatoid arthritis in adults: remicade, in combination with methotrexate, is indicated for the reduction of signs and symptoms and prevention of structural joint damage (erosions and joint space narrowing) in: patients with active disease despite treatment with methotrexate; patients with active disease who have not previously received methotrexate. remicade should be given in combination with methotrexate. efficacy and safety in rheumatoid arthritis have been demonstrated only in combination with methotrexate. ankylosing spondylitis: remicade is indicated for the reduction of signs and symptoms and improvement in physical function in patients with active disease. psoriatic arthritis: remicade is indicated for the treatment of the signs and symptoms, as well as for the improvement in physical function in adult patients with active and progressive psoriatic arthritis who have responded inadequately to disease-modifying anti-rheumatic drug (dmard) therapy. remicade may be administered in combination with methotrexate. psoriasis: remicade is indicated for the treatment of adult patients with moderate to severe plaque psoriasis for whom phototherapy or conventional systemic treatments have been inadequate or are inappropriate. safety and efficacy beyond 12 months have not been established. crohn's disease in adults and in children and adolescents (6-17 years): remicade is indicated for the treatment of moderate to severe crohn's disease, to reduce the signs and symptoms and to induce and maintain clinical remission in patients who have an inadequate response to conventional therapies. refractory fistulising crohn's disease: remicade is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients. ulcerative colitis in adults and in children and adolescents (6 to 17 years); remicade is indicated for the treatment of moderately severe to severe active ulcerative colitis in patients who have had an inadequate response to conventional therapy.

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

janssen-cilag pty ltd - ibrutinib, quantity: 560 mg - tablet, film coated - excipient ingredients: lactose monohydrate; croscarmellose sodium; sodium lauryl sulfate; povidone; microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - imbruvica is indicated for the treatment of patients with mcl who have received at least one prior therapy.,imbruvica as a single agent is indicated for the treatment of adult patients with waldenstr?m?s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.,imbruvica in combination with rituximab is indicated for the treatment of adult patients with waldenstrom?s macroglobulinaemia (wm).,imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia/small lymphocytic lymphoma (cll/sll).,imbruvica as a single agent or in combination with bendamustine and rituximab (br) is indicated for the treatment of adult patients with chronic lymphocytic leukaemia/small lymphocytic lymphoma (cll/sll) who have received at least one prior therapy.

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

janssen-cilag pty ltd - ibrutinib, quantity: 420 mg - tablet, film coated - excipient ingredients: lactose monohydrate; croscarmellose sodium; sodium lauryl sulfate; povidone; microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; iron oxide black - imbruvica is indicated for the treatment of patients with mcl who have received at least one prior therapy.,imbruvica as a single agent is indicated for the treatment of adult patients with waldenstr?m?s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.,imbruvica in combination with rituximab is indicated for the treatment of adult patients with waldenstrom?s macroglobulinaemia (wm).,imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia/small lymphocytic lymphoma (cll/sll).,imbruvica as a single agent or in combination with bendamustine and rituximab (br) is indicated for the treatment of adult patients with chronic lymphocytic leukaemia/small lymphocytic lymphoma (cll/sll) who have received at least one prior therapy.

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

janssen-cilag pty ltd - ibrutinib, quantity: 280 mg - tablet, film coated - excipient ingredients: lactose monohydrate; croscarmellose sodium; sodium lauryl sulfate; povidone; microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - imbruvica is indicated for the treatment of patients with mcl who have received at least one prior therapy.,imbruvica as a single agent is indicated for the treatment of adult patients with waldenstr?m?s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.,imbruvica in combination with rituximab is indicated for the treatment of adult patients with waldenstrom?s macroglobulinaemia (wm).,imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia/small lymphocytic lymphoma (cll/sll).,imbruvica as a single agent or in combination with bendamustine and rituximab (br) is indicated for the treatment of adult patients with chronic lymphocytic leukaemia/small lymphocytic lymphoma (cll/sll) who have received at least one prior therapy.

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

janssen-cilag pty ltd - ibrutinib, quantity: 140 mg - tablet, film coated - excipient ingredients: lactose monohydrate; croscarmellose sodium; sodium lauryl sulfate; povidone; microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; iron oxide black - imbruvica is indicated for the treatment of patients with mcl who have received at least one prior therapy.,imbruvica as a single agent is indicated for the treatment of adult patients with waldenstr?m?s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.,imbruvica in combination with rituximab is indicated for the treatment of adult patients with waldenstrom?s macroglobulinaemia (wm).,imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia/small lymphocytic lymphoma (cll/sll).,imbruvica as a single agent or in combination with bendamustine and rituximab (br) is indicated for the treatment of adult patients with chronic lymphocytic leukaemia/small lymphocytic lymphoma (cll/sll) who have received at least one prior therapy.

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

celltrion healthcare australia pty ltd - infliximab, quantity: 120 mg - injection, solution - excipient ingredients: acetic acid; sodium acetate trihydrate; sorbitol; polysorbate 80; water for injections - rheumatoid arthritis in adults remsima in combination with methotrexate, is indicated for the reduction of signs and symptoms and prevention of structural joint damage (erosions and joint space narrowing) in: - patients with active disease despite treatment with methotrexate - patients with active disease who have not previously received methotrexate.,remsima should be given in combination with methotrexate. efficacy and safety in rheumatoid arthritis have been demonstrated only in combination with methotrexate.,ankylosing spondylitis remsima is indicated for the reduction of signs and symptoms and improvement in physical function in patients with active disease.,psoriatic arthritis remsima is indicated for the treatment of the signs and symptoms, as well as for the improvement in physical function in adult patients with active and progressive psoriatic arthritis who have responded inadequately to disease-modifying anti-rheumatic drug (dmard) therapy. remsima may be administered in combination with methotrexate.,psoriasis remsima is indicated for the treatment of adult patients with moderate to severe plaque psoriasis for whom phototherapy or conventional systemic treatments have been inadequate or are inappropriate. safety and efficacy beyond 12 months have not been established.,crohn?s disease in adults remsima is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms and to induce and maintain clinical remission in patients who have an inadequate response to conventional therapies.,refractory fistulising crohn?s disease remsima is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients.,ulcerative colitis in adults remsimais indicated for the treatment of moderately severe to severe active ulcerative colitis in patients who have had an inadequate response to conventional therapy.

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

celltrion healthcare australia pty ltd - infliximab, quantity: 120 mg - injection, solution - excipient ingredients: acetic acid; sodium acetate trihydrate; sorbitol; polysorbate 80; water for injections - rheumatoid arthritis in adults remsima in combination with methotrexate, is indicated for the reduction of signs and symptoms and prevention of structural joint damage (erosions and joint space narrowing) in: - patients with active disease despite treatment with methotrexate - patients with active disease who have not previously received methotrexate.,remsima should be given in combination with methotrexate. efficacy and safety in rheumatoid arthritis have been demonstrated only in combination with methotrexate.,ankylosing spondylitis remsima is indicated for the reduction of signs and symptoms and improvement in physical function in patients with active disease.,psoriatic arthritis remsima is indicated for the treatment of the signs and symptoms, as well as for the improvement in physical function in adult patients with active and progressive psoriatic arthritis who have responded inadequately to disease-modifying anti-rheumatic drug (dmard) therapy. remsima may be administered in combination with methotrexate.,psoriasis remsima is indicated for the treatment of adult patients with moderate to severe plaque psoriasis for whom phototherapy or conventional systemic treatments have been inadequate or are inappropriate. safety and efficacy beyond 12 months have not been established.,crohn?s disease in adults remsima is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms and to induce and maintain clinical remission in patients who have an inadequate response to conventional therapies.,refractory fistulising crohn?s disease remsima is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients.,ulcerative colitis in adults remsimais indicated for the treatment of moderately severe to severe active ulcerative colitis in patients who have had an inadequate response to conventional therapy.