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

cipla australia pty ltd - bevacizumab, quantity: 25 mg/ml - injection, concentrated - excipient ingredients: monobasic sodium phosphate monohydrate; water for injections; dibasic sodium phosphate; polysorbate 20; trehalose dihydrate - metastatic colorectal cancer bevaciptin (bevacizumab) in combination with fluoropyrimidine-based chemotherapy is indicated for the treatment of patients with metastatic colorectal cancer. locally recurrent or metastatic breast cancer bevaciptin (bevacizumab) in combination with paclitaxel is indicated for the first-line treatment of metastatic breast cancer in patients in whom an anthracycline-based therapy is contraindicated (see section 5.1 clinical trials). advanced, metastatic or recurrent non-squamous non-small cell lung cancer (nsclc) bevaciptin (bevacizumab), in combination with carboplatin and paclitaxel, is indicated for first- line treatment of patients with unresectable advanced, metastatic or recurrent, non-squamous, non-small cell lung cancer. advanced and/or metastatic renal cell cancer bevaciptin (bevacizumab) in combination with interferon alfa-2a is indicated for treatment of patients with advanced and/or metastatic renal cell cancer. grade iv glioma bevaciptin (bevacizumab) as a single agent, is indicated for the treatment of patients with grade iv glioma after relapse or disease progression after standard therapy, including chemotherapy. epithelial ovarian, fallopian tube or primary peritoneal cancer bevaciptin (bevacizumab) in combination with carboplatin and paclitaxel, is indicated for first- line treatment of patients with advanced (figo stages iiib, iiic and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer. recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer bevaciptin (bevacizumab) in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, is indicated for the treatment of patients with first recurrence of platinum-sensitive, epithelial ovarian, fallopian tube, or primary peritoneal cancer who have not received prior bevacizumab or other vegf-targeted angiogenesis inhibitors. bevaciptin (bevacizumab) in combination with topotecan or pegylated liposomal doxorubicin is indicated for the treatment of patients with recurrent, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received no more than two prior chemotherapy regimens, and have not received any prior anti-angiogenic therapy including bevacizumab. cervical cancer bevaciptin (bevacizumab) in combination with paclitaxel and cisplatin is indicated for the treatment of persistent, recurrent or metastatic carcinoma of the cervix. bevaciptin (bevacizumab) in combination with paclitaxel and topotecan is an acceptable alternative where cisplatin is not tolerated or not indicated.

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

cipla australia pty ltd - bevacizumab, quantity: 25 mg/ml - injection, concentrated - excipient ingredients: monobasic sodium phosphate monohydrate; water for injections; trehalose dihydrate; dibasic sodium phosphate; polysorbate 20 - metastatic colorectal cancer bevaciptin (bevacizumab) in combination with fluoropyrimidine-based chemotherapy is indicated for the treatment of patients with metastatic colorectal cancer. locally recurrent or metastatic breast cancer bevaciptin (bevacizumab) in combination with paclitaxel is indicated for the first-line treatment of metastatic breast cancer in patients in whom an anthracycline-based therapy is contraindicated (see section 5.1 clinical trials). advanced, metastatic or recurrent non-squamous non-small cell lung cancer (nsclc) bevaciptin (bevacizumab), in combination with carboplatin and paclitaxel, is indicated for first- line treatment of patients with unresectable advanced, metastatic or recurrent, non-squamous, non-small cell lung cancer. advanced and/or metastatic renal cell cancer bevaciptin (bevacizumab) in combination with interferon alfa-2a is indicated for treatment of patients with advanced and/or metastatic renal cell cancer. grade iv glioma bevaciptin (bevacizumab) as a single agent, is indicated for the treatment of patients with grade iv glioma after relapse or disease progression after standard therapy, including chemotherapy. epithelial ovarian, fallopian tube or primary peritoneal cancer bevaciptin (bevacizumab) in combination with carboplatin and paclitaxel, is indicated for first- line treatment of patients with advanced (figo stages iiib, iiic and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer. recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer bevaciptin (bevacizumab) in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, is indicated for the treatment of patients with first recurrence of platinum-sensitive, epithelial ovarian, fallopian tube, or primary peritoneal cancer who have not received prior bevacizumab or other vegf-targeted angiogenesis inhibitors. bevaciptin (bevacizumab) in combination with topotecan or pegylated liposomal doxorubicin is indicated for the treatment of patients with recurrent, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received no more than two prior chemotherapy regimens, and have not received any prior anti-angiogenic therapy including bevacizumab. cervical cancer bevaciptin (bevacizumab) in combination with paclitaxel and cisplatin is indicated for the treatment of persistent, recurrent or metastatic carcinoma of the cervix. bevaciptin (bevacizumab) in combination with paclitaxel and topotecan is an acceptable alternative where cisplatin is not tolerated or not indicated.

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

maxx pharma pty ltd - etanercept, quantity: 50 mg - injection, solution - excipient ingredients: water for injections; sodium chloride; glycine; sucrose; sodium citrate dihydrate; monobasic sodium phosphate dihydrate - nepexto is indicated for the treatment of:,adults,rheumatoid arthritis,active, adult rheumatoid arthritis (ra) in patients who have had inadequate response to one or more disease-modifying antirheumatic drugs (dmards). nepexto can be used in combination with methotrexate.,severe, active rheumatoid arthritis in adults to slow progression of disease-associated structural damage in patients at high risk of erosive disease.,psoriatic arthritis,the signs and symptoms of active and progressive psoriatic arthritis in adults, when the response to previous disease-modifying antirheumatic therapy has been inadequate. etanercept has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function.,plaque psoriasis,adult patients with moderate to severe chronic plaque psoriasis, who are candidates for phototherapy or systemic therapy.,ankylosing spondylitis,the signs and symptoms of active ankylosing spondylitis in adults.,non-radiographic axial spondyloarthritis,treatment of adults with active* non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or mri change who have had an inadequate response to nsaids.,* active disease is defined as a bath ankylosing spondylitis disease activity index (basdai) score of >= 4.,children and adolescents,children and adolescents weighing less than 62.5 kg should not receive nepexto. these patients should be accurately dosed on a mg/kg basis with other etanercept products.,juvenile idiopathic arthritis,active polyarthritis (rheumatoid factor positive or negative) in children and adolescents, aged 2 to 17 years, who have had an inadequate response to one or more dmards.,active extended oligoarthritis in children and adolescents, aged 2 to 17 years, who have had an inadequate response to, or who have proved intolerant to, methotrexate.,active enthesitis-related arthritis in adolescents, aged 12 to 17 years, who have had an inadequate response to, or who have proved intolerant to, conventional therapy.,active psoriatic arthritis in adolescents, aged 12 to 17 years, who have had an inadequate response to, or who have proved intolerant to, methotrexate.,etanercept has not been studied in children aged less than 2 years.,paediatric plaque psoriasis,chronic, severe plaque psoriasis in children and adolescents from 4 to 17 years, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. duration of therapy to be no longer than 24 weeks and treatment to be ceased after 12 weeks if a significant psoriasis area and severity index (pasi) response is not achieved.

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

cipla australia pty ltd - adalimumab, quantity: 80 mg - injection, solution - excipient ingredients: sodium chloride; sucrose; polysorbate 80; water for injections - rheumatoid arthritis,adalicip is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. adalicip can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis,polyarticular juvenile idiopathic arthritis,adalicip in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older weighing greater than or equal to 30 kg who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). adalicip can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis,adalicip is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis,adalicip is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis,adalicip is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis. crohn?s disease in adults and children (greater than or equal to 6 years; weighing greater than or equal to 40 kg) adalicip is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; ? who have had an inadequate response to conventional therapies or, ? who have lost response to or are intolerant to infliximab,ulcerative colitis,adalicip is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time (see section 5.1 pharmacodynamic properties -clinical trials).,psoriasis in adults and children,adalicip is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,adalicip is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age weighing greater than or equal to 40 kg who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age),adalicip is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis,adalicip is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

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

cipla australia pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: sodium chloride; sucrose; polysorbate 80; water for injections - rheumatoid arthritis,adalicip is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. adalicip can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis,polyarticular juvenile idiopathic arthritis,adalicip in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older weighing greater than or equal to 30 kg who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). adalicip can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis,adalicip is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis,adalicip is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis,adalicip is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis. crohn?s disease in adults and children (greater than or equal to 6 years; weighing greater than or equal to 40 kg) adalicip is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; ? who have had an inadequate response to conventional therapies or, ? who have lost response to or are intolerant to infliximab,ulcerative colitis,adalicip is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time (see section 5.1 pharmacodynamic properties -clinical trials).,psoriasis in adults and children,adalicip is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,adalicip is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age weighing greater than or equal to 40 kg who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age),adalicip is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis,adalicip is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

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

cipla australia pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: sodium chloride; sucrose; polysorbate 80; water for injections - rheumatoid arthritis,adalicip is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. adalicip can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis,polyarticular juvenile idiopathic arthritis,adalicip in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older weighing greater than or equal to 30 kg who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). adalicip can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis,adalicip is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis,adalicip is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis,adalicip is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis. crohn?s disease in adults and children (greater than or equal to 6 years; weighing greater than or equal to 40 kg) adalicip is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; ? who have had an inadequate response to conventional therapies or, ? who have lost response to or are intolerant to infliximab,ulcerative colitis,adalicip is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time (see section 5.1 pharmacodynamic properties -clinical trials).,psoriasis in adults and children,adalicip is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,adalicip is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age weighing greater than or equal to 40 kg who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age),adalicip is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis,adalicip is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

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

australian antarctic ocean bio-technology pty ltd - euphausia superba oil, quantity: 500 mg - capsule, soft - excipient ingredients: vanillin; glycerol; gelatin; soya oil; sorbitol solution (70 per cent) (non-crystallising); purified water - antioxidant/reduce free radicals formed in the body ; helps reduce/decrease free radical damage to body cells ; maintain/support eye health ; helps enhance/promote general health and wellbeing ; maintain/support general health and wellbeing ; maintain/support heart health ; maintain/support brain health

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

australian antarctic ocean bio-technology pty ltd - silybum marianum -

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

australian antarctic ocean bio-technology pty ltd - vitis vinifera, quantity: 200 mg; vitis vinifera, quantity: 166.7 mg (equivalent: vitis vinifera, qty 20 g) - capsule, soft - excipient ingredients: gelatin; allura red ac; glycerol; brilliant blue fcf; soya oil; white beeswax; purified water; titanium dioxide; hydrogenated coconut oil; lecithin - antioxidant/reduce free radicals formed in the body ; helps reduce/decrease free radical damage to body cells ; helps enhance/promote general health and wellbeing ; maintain/support general health and wellbeing

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

australian antarctic ocean bio-technology pty ltd - propolis, quantity: 2 g (equivalent: lead, qty 800 ng; equivalent: propolis dry extract, qty 400 mg) - capsule, soft - excipient ingredients: gelatin; white beeswax; hydrogenated vegetable oil; soya oil; lecithin; iron oxide black; purified water; iron oxide red; glycerol; grape seed oil - antioxidant/reduce free radicals formed in the body ; helps reduce/decrease free radical damage to body cells ; maintain/support general health and wellbeing ; maintain/support immune system health ; maintain/support healthy immune system function