Austrália - inglês - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - paliperidone palmitate, quantity: 312 mg/ml (equivalent: paliperidone, qty 200 mg/ml) - injection, suspension - excipient ingredients: polysorbate 20; macrogol 4000; citric acid monohydrate; monobasic sodium phosphate monohydrate; sodium hydroxide; water for injections - indicated for the maintenance treatment of schizophrenia in adult patients who have been adequately treated with the 1-month paliperidone palmitate injectable product for at least four months.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - bortezomib, quantity: 3 mg - injection, powder for - excipient ingredients: mannitol; nitrogen - - velcade, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy. - velcade, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma. - velcade is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease. - velcade in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - darunavir, quantity: 800 mg; cobicistat, quantity: 150 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; crospovidone; silicon dioxide; magnesium stearate; hypromellose; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - prezcobix, a fixed dose combination of darunavir and cobicistat, is indicated in combination with other antiretroviral agents for the treatment of adult patients with human immunodeficiency virus- 1 (hiv-1) infection in:,- antiretroviral treatment-naive patients,- antiretroviral treatment-experienced patients with no darunavir resistance associated mutations and who have plasma hiv-1 rna <100,000 copies/ml,- antiretroviral treatment-experienced but hiv protease inhibitor-naive patients for whom hiv-1 genotype testing is unavailable (see section 4.2 dose and method of administration)

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - ibrutinib, quantity: 140 mg - capsule, hard - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; sodium lauryl sulfate; magnesium stearate; titanium dioxide; potable water; gelatin; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - 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.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - bendamustine hydrochloride, quantity: 25 mg - injection, powder for - excipient ingredients: mannitol - first-line treatment of chronic lymphocytic leukaemia (binet stage b or c). efficacy relative to first-line therapies other than chlorambucil has not been established. previously untreated indolent cd20-positive, stage iii-iv non-hodgkin?s lymphoma, in combination with rituximab. previously untreated cd20-positive, stage iii-iv mantle cell lymphoma in combination with rituximab, in patients ineligible for autologous stem cell transplantation. relapsed/refractory indolent non-hodgkin?s lymphoma.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - bendamustine hydrochloride, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - first-line treatment of chronic lymphocytic leukaemia (binet stage b or c). efficacy relative to first-line therapies other than chlorambucil has not been established. previously untreated indolent cd20-positive, stage iii-iv non-hodgkin?s lymphoma, in combination with rituximab. previously untreated cd20-positive, stage iii-iv mantle cell lymphoma in combination with rituximab, in patients ineligible for autologous stem cell transplantation. relapsed/refractory indolent non-hodgkin?s lymphoma.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - golimumab, quantity: 100 mg/ml - injection, solution - excipient ingredients: sorbitol; histidine; polysorbate 80; water for injections - simponi,rheumatoid arthritis (ra),simponi, in combination with methotrexate, is indicated for:,the treatment of moderate to severely active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drug therapy, including methotrexate, has been inadequate. simponi has also been shown to inhibit the progression of joint damage as measured by x-ray.,psoriatic arthritis (psa),simponi, alone or in combination with methotrexate, is indicated for:,the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. simponi has also been shown to inhibit the progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease, and improve physical function.,axial spondyloarthritis,ankylosing spondylitis (as),simponi is indicated for:,the treatment of active ankylosing spondylitis in adult patients. non-radiographic axial spondyloarthritis (nr-axial spa),simponi is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) evidence, who have had an inadequate response to, or are intolerant to, nonsteroidal anti-inflammatory drugs (nsaids).,ulcerative colitis (uc),simponi is indicated for: the treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy. patients should show a clinical response within 6 weeks of treatment to continue treatment beyond that time (see section 5.1 pharmacodynamic properties, clinical trials).

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - golimumab, quantity: 100 mg/ml - injection, solution - excipient ingredients: sorbitol; polysorbate 80; water for injections; histidine - simponi,rheumatoid arthritis (ra),simponi, in combination with methotrexate, is indicated for:,the treatment of moderate to severely active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drug therapy, including methotrexate, has been inadequate. simponi has also been shown to inhibit the progression of joint damage as measured by x-ray.,psoriatic arthritis (psa),simponi, alone or in combination with methotrexate, is indicated for:,the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. simponi has also been shown to inhibit the progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease, and improve physical function.,axial spondyloarthritis,ankylosing spondylitis (as),simponi is indicated for:,the treatment of active ankylosing spondylitis in adult patients. non-radiographic axial spondyloarthritis (nr-axial spa),simponi is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) evidence, who have had an inadequate response to, or are intolerant to, nonsteroidal anti-inflammatory drugs (nsaids).,ulcerative colitis (uc),simponi is indicated for: the treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy. patients should show a clinical response within 6 weeks of treatment to continue treatment beyond that time (see section 5.1 pharmacodynamic properties, clinical trials).

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - canagliflozin hemihydrate -

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - canagliflozin hemihydrate -