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

accelagen pty ltd - sunitinib malate, quantity: 33.412 mg (equivalent: sunitinib, qty 25 mg) - capsule, hard - excipient ingredients: titanium dioxide; gelatin; iron oxide red; mannitol; croscarmellose sodium; magnesium stearate; pregelatinised maize starch; iron oxide black; iron oxide yellow; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; shellac; ethanol absolute; ammonia; potassium hydroxide - sunitinib msn is indicated for;,treatment of advanced renal cell carcinoma (rcc),treatment of gastrointestinal stromal tumour (gist) after failure of imatinib mesilate treatment due to resistance or intolerance,treatment of unresectable, well-differentiated pancreatic neuroendocrine tumours (pancreatic net)

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

accelagen pty ltd - sunitinib malate, quantity: 16.706 mg (equivalent: sunitinib, qty 12.5 mg) - capsule, hard - excipient ingredients: magnesium stearate; mannitol; titanium dioxide; croscarmellose sodium; gelatin; pregelatinised maize starch; iron oxide red; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; shellac; ethanol absolute; ammonia; potassium hydroxide - sunitinib msn is indicated for;,treatment of advanced renal cell carcinoma (rcc),treatment of gastrointestinal stromal tumour (gist) after failure of imatinib mesilate treatment due to resistance or intolerance,treatment of unresectable, well-differentiated pancreatic neuroendocrine tumours (pancreatic net)

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

accelagen pty ltd - sunitinib malate, quantity: 33.412 mg (equivalent: sunitinib, qty 25 mg) - capsule, hard - excipient ingredients: iron oxide yellow; mannitol; croscarmellose sodium; titanium dioxide; iron oxide red; gelatin; pregelatinised maize starch; magnesium stearate; iron oxide black; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; shellac; ethanol absolute; ammonia; potassium hydroxide - sunitinib msn is indicated for;,treatment of advanced renal cell carcinoma (rcc),treatment of gastrointestinal stromal tumour (gist) after failure of imatinib mesilate treatment due to resistance or intolerance,treatment of unresectable, well-differentiated pancreatic neuroendocrine tumours (pancreatic net)

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

gilead sciences pty ltd - velpatasvir, quantity: 100 mg; sofosbuvir, quantity: 400 mg - tablet, film coated - excipient ingredients: magnesium stearate; croscarmellose sodium; copovidone; silicified microcrystalline cellulose; titanium dioxide; purified talc; iron oxide red; macrogol 4000; polyvinyl alcohol - epclusa is indicated for the treatment of chronic hepatitis c virus (hcv) infection (genotype 1, 2, 3, 4, 5 or 6) in adults and paediatric patients 12 years of age and older and weighing 30 kg or more.,(see 4.2 dose and method of administration section for the recommended regimens for different patient subgroups).

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

janssen-cilag pty ltd - paliperidone, quantity: 9 mg - tablet, modified release - excipient ingredients: sodium chloride; iron oxide red; purified water; hyetellose; macrogol 3350; carnauba wax; butylated hydroxytoluene; polyethylene oxide; povidone; stearic acid; isopropyl alcohol; propylene glycol; iron oxide black; hypromellose; titanium dioxide; macrogol 400; cellulose acetate - invega is indicated for the treatment of schizophrenia, including acute treatment and recurrence prevention. invega is indicated for the treatment of acute exacerbations of schizoaffective disorder as monotherapy and in combination with antidepressants and/or mood stabilizers (lithium and valproate).

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

janssen-cilag pty ltd - paliperidone, quantity: 6 mg - tablet, modified release - excipient ingredients: butylated hydroxytoluene; sodium chloride; povidone; stearic acid; polyethylene oxide; iron oxide red; hyetellose; macrogol 3350; macrogol 400; carnauba wax; isopropyl alcohol; propylene glycol; cellulose acetate; titanium dioxide; hypromellose; purified water; iron oxide black; iron oxide yellow - invega is indicated for the treatment of schizophrenia, including acute treatment and recurrence prevention. invega is indicated for the treatment of acute exacerbations of schizoaffective disorder as monotherapy and in combination with antidepressants and/or mood stabilizers (lithium and valproate).

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

janssen-cilag pty ltd - paliperidone, quantity: 3 mg - tablet, modified release - excipient ingredients: polyethylene oxide; iron oxide yellow; iron oxide red; butylated hydroxytoluene; purified water; carnauba wax; sodium chloride; hypromellose; iron oxide black; lactose monohydrate; triacetin; stearic acid; povidone; macrogol 3350; titanium dioxide; hyetellose; isopropyl alcohol; cellulose acetate; propylene glycol - invega is indicated for the treatment of schizophrenia, including acute treatment and recurrence prevention. invega is indicated for the treatment of acute exacerbations of schizoaffective disorder as monotherapy and in combination with antidepressants and/or mood stabilizers (lithium and valproate).

Australia - English - 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 - English - 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 - English - 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.