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

roche products pty ltd - methoxy polyethylene glycol-epoetin beta, quantity: 0.1 mg - injection, solution - excipient ingredients: sodium sulfate; poloxamer; monobasic sodium phosphate monohydrate; mannitol; methionine; water for injections - mircera is indicated for the treatment of anaemia associated with chronic kidney disease (ckd).

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

roche products pty ltd - methoxy polyethylene glycol-epoetin beta, quantity: 0.2 mg - injection, solution - excipient ingredients: poloxamer; sodium sulfate; methionine; mannitol; monobasic sodium phosphate monohydrate; water for injections - mircera is indicated for the treatment of anaemia associated with chronic kidney disease (ckd).

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

roche products pty ltd - methoxy polyethylene glycol-epoetin beta, quantity: 0.36 mg - injection, solution - excipient ingredients: monobasic sodium phosphate monohydrate; sodium sulfate; poloxamer; mannitol; methionine; water for injections - mircera is indicated for the treatment of anaemia associated with chronic kidney disease (ckd).

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

roche products pty ltd - methoxy polyethylene glycol-epoetin beta, quantity: 0.075 mg - injection, solution - excipient ingredients: mannitol; methionine; monobasic sodium phosphate monohydrate; poloxamer; sodium sulfate; water for injections - mircera is indicated for the treatment of anaemia associated with chronic kidney disease (ckd).

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

roche products pty ltd - pertuzumab, quantity: 420 mg - injection, intravenous infusion - excipient ingredients: histidine; sucrose; glacial acetic acid; water for injections; polysorbate 20 - early breast cancer perjeta is indicated in combination with trastuzumab and chemotherapy for:,- the neoadjuvant treatment of patients with her2-positive inflammatory or locally advanced, or early stage (either > 2 cm in diameter or node positive) breast cancer as part of a complete treatment regimen for early breast cancer,-the adjuvant treatment of patients with her2-positive early breast cancer at high risk of recurrence.,metastatic breast cancer,perjeta is indicated in combination with trastuzumab and docetaxel for patients with metastatic her2-positive breast cancer who have not received prior anti-her2 therapy or chemotherapy for their metastatic disease.

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

roche products pty ltd - trastuzumab, quantity: 150 mg - injection, powder for - excipient ingredients: histidine; histidine hydrochloride monohydrate; trehalose dihydrate; polysorbate 20 - early breast cancer. herceptin is indicated for the treatment of patients with her2 positive localised breast cancer following surgery, and in assocoation with chemotherapy and, if applicable, radiotherapy. locally advanced breast cancer.herceptin is indicated for the treatment of her2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant herceptin. metastatic breast cancer. herceptin is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress her2: a) as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease, b) in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or c) in combination with an aromatase inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer. advanced gastric cancer. herceptin is indicated in combination with cisplatin and either capecitabine or 5-fu for the treatment of patients with her2 positive advanced adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.

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

roche products pty ltd - rituximab, quantity: 10 mg/ml - injection, concentrated - excipient ingredients: polysorbate 80; sodium chloride; water for injections; sodium hydroxide; hydrochloric acid; citric acid; sodium citrate dihydrate - non-hodgkin's lymphoma: mabthera is indicated for treatment of patients with: cd20 positive, previously untreated, stage iii/iv follicular, b-cell non-hodgkin's lymphoma. cd20 positive, relapsed or refractory low grade or follicular, b-cell non-hodgkin's lymphoma, cd20 positive, diffuse large b-cell non-hodgkin's lymphoma, in combination with chemotherapy. chronic lymphocytic leukaemia: mabthera is indicated for the treatment of patients with cd20 positive chronic lymphocytic leukaemia (cll) in combination with chemotherapy. rheumatoid arthritis: mabthera (rituximab) in combination with methotrexate is indicated for the treatment of adult patients with severe, active rheumatoid arthritis who have had an inadequate response or intolerance to at least one tumour necrosis factor (tnf) inhibitor therapy. mabthera has been shown to reduce the rate of progression of joint damage as measured by x-ray when given in combination with methotrexate. granulomatosis with polyangiitis (wegener's ) (gpa) and microscopic poly

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

roche products pty ltd - rituximab, quantity: 10 mg/ml - injection, concentrated - excipient ingredients: sodium chloride; water for injections; citric acid; polysorbate 80; hydrochloric acid; sodium citrate dihydrate; sodium hydroxide - non-hodgkin's lymphoma: mabthera is indicated for treatment of patients with: cd20 positive, previously untreated, stage iii/iv follicular, b-cell non-hodgkin's lymphoma. cd20 positive, relapsed or refractory low grade or follicular, b-cell non-hodgkin's lymphoma, cd20 positive, diffuse large b-cell non-hodgkin's lymphoma, in combination with chemotherapy. chronic lymphocytic leukaemia: mabthera is indicated for the treatment of patients with cd20 positive chronic lymphocytic leukaemia (cll) in combination with chemotherapy. rheumatoid arthritis: mabthera (rituximab) in combination with methotrexate is indicated for the treatment of adult patients with severe, active rheumatoid arthritis who have had an inadequate response or intolerance to at least one tumour necrosis factor (tnf) inhibitor therapy. mabthera has been shown to reduce the rate of progression of joint damage as measured by x-ray when given in combination with methotrexate. granulomatosis with polyangiitis (wegener's ) (gpa) and microscopic poly

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

roche products pty ltd - tocilizumab, quantity: 162 mg - injection, solution - excipient ingredients: polysorbate 80; arginine; arginine hydrochloride; methionine; histidine; histidine hydrochloride monohydrate; water for injections - rheumatoid arthritis (iv and sc formulations),actemra is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients in combination with methotrexate (mtx) or other non-biological disease-modifying anti-rheumatic drugs (dmards) in case of either an inadequate response or intolerance to previous therapy with one or more dmards.,actemra is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors (see section 5.1 pharmacodynamic properties, clinical trials) in combination with mtx in those not previously treated with mtx.,in the two groups of patients above, actemra can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate.,actemra has been shown to inhibit the progression of joint damage in adults, as measured by x-ray, when given in combination with methotrexate.,giant cell arteritis (sc formulations only),actemra is indicated for the treatment of giant cell arteritis (gca) in adult patients.,polyarticular juvenile idiopathic arthritis (iv and sc formulations),actemra is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to or intolerance to methotrexate (mtx). actemra can be given alone or in combination with mtx.,systemic juvenile idiopathic arthritis (iv and sc formulations),intravenous formulation,actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.,subcutaneous formulation,actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 1 year of age and older.,actemra iv and sc can be given alone or in combination with methotrexate (mtx).

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

roche products pty ltd - pirfenidone, quantity: 801 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; colloidal anhydrous silica; povidone; croscarmellose sodium; magnesium stearate; polyvinyl alcohol; titanium dioxide; macrogol 3350; purified talc; iron oxide red; iron oxide black - esbriet is indicated for the treatment of idiopathic pulmonary fibrosis (ipf).