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

roche products pty ltd - pirfenidone, quantity: 534 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 yellow; iron oxide red - esbriet is indicated for the treatment of idiopathic pulmonary fibrosis (ipf).

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

roche products pty ltd - pirfenidone, quantity: 267 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 yellow - esbriet is indicated for the treatment of idiopathic pulmonary fibrosis (ipf).

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

roche products pty ltd - tocilizumab, quantity: 162 mg - injection, solution - excipient ingredients: polysorbate 80; 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 - tocilizumab, quantity: 162 mg - injection, solution - excipient ingredients: polysorbate 80; 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 - imdevimab, quantity: 120 mg/ml - injection, solution - excipient ingredients: histidine; histidine hydrochloride monohydrate; sucrose; polysorbate 80; water for injections - ronapreve has provisional approval for the indications below:,treatment:,ronapreve is indicated for the treatment of covid-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg) who do not require supplemental oxygen for covid-19 and who are at increased risk of progressing to severe covid-19.,post-exposure prophylaxis:,ronapreve is indicated for the prevention of covid-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg) who have been exposed to sars-cov-2 and who either:,? have a medical condition making them unlikely to respond to or be protected by vaccination, or,? are not vaccinated against covid-19. (,refer to section 4.2 dose and method of administration and section 5.1, clinical trials),ronapreve is not intended to be used as a substitute for vaccination against covid-19.,the decision has been made on the basis of short term efficacy and safety data. continued approval of this indication depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.,the use of ronapreve should take into account information on the activity of ronapreve against viral variants of concern. see sections 4.4 and 5.1.

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

roche products pty ltd - imdevimab, quantity: 120 mg/ml - injection, solution - excipient ingredients: histidine; histidine hydrochloride monohydrate; sucrose; polysorbate 80; water for injections - ronapreve has provisional approval for the indications below:,treatment:,ronapreve is indicated for the treatment of covid-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg) who do not require supplemental oxygen for covid-19 and who are at increased risk of progressing to severe covid-19.,post-exposure prophylaxis:,ronapreve is indicated for the prevention of covid-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg) who have been exposed to sars-cov-2 and who either:,? have a medical condition making them unlikely to respond to or be protected by vaccination, or,? are not vaccinated against covid-19.,(refer to section 4.2 dose and method of administration and 5.1, clinical trials),ronapreve is not intended to be used as a substitute for vaccination against covid-19.,the decision has been made on the basis of short term efficacy and safety data. continued approval of this indication depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.,the use of ronapreve should take into account information on the activity of ronapreve against viral variants of concern. see sections 4.4 and 5.1.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

grochem australia pty ltd - thiram - water dispersible granule - thiram carbamate-dithiocarbamate active 800.0 g/kg - fungicide

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

roche products pty ltd - enfuvirtide -

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

roche products pty ltd - erlotinib hydrochloride, quantity: 163.93 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; sodium starch glycollate; magnesium stearate; sodium lauryl sulfate; lactose monohydrate; titanium dioxide; hypromellose; hyprolose; macrogol 400 - non-small cell lung cancer: tarceva is indicated for the first-line treatment of patients with advanced (stage iiib) or metastatic (stage iv) non-small cell lung cancer (nsclc) with activating egfr mutations. tarceva is indicated for maintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating egfr mutations who have not progressed on first-line chemotherapy. tarceva is also indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy. pancreatic cancer: tarceva in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

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

roche products pty ltd - erlotinib hydrochloride, quantity: 109.29 mg - tablet, film coated - excipient ingredients: sodium lauryl sulfate; sodium starch glycollate; microcrystalline cellulose; magnesium stearate; lactose monohydrate; titanium dioxide; hypromellose; hyprolose; macrogol 400 - non-small cell lung cancer: tarceva is indicated for the first-line treatment of patients with advanced (stage iiib) or metastatic (stage iv) non-small cell lung cancer (nsclc) with activating egfr mutations. tarceva is indicated for maintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating egfr mutations who have not progressed on first-line chemotherapy. tarceva is also indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy. pancreatic cancer: tarceva in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.