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

besins healthcare australia pty ltd - estradiol hemihydrate, quantity: 0.06 % w/w (equivalent: estradiol, qty 0.06 % w/w) - gel - excipient ingredients: carbomer 980; trolamine; ethanol; purified water - - hormone replacement therapy (hrt) for estrogen deficiency symptoms in postmenopausal women.,- prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis. (see also section 4.4 special warnings and precautions for use),the experience treating women older than 65 years is limited. the lowest effective dose should be used for the shortest duration (see sections 4.2 dose and method of administration and 4.4 special warnings and precautions for use).

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

celltrion healthcare australia pty ltd - trastuzumab, quantity: 150 mg - injection, powder for - excipient ingredients: histidine hydrochloride; polysorbate 20; histidine; trehalose dihydrate - early breast cancer,indicated for the treatment of her2-positive early breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy.,locally advanced breast cancer,indicated for the treatment of her2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant therapy.,metastatic breast cancer,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,indicated in combination with cisplatin and either capecitabine or 5-fu for the treatmen

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

celltrion healthcare australia pty ltd - trastuzumab, quantity: 150 mg - injection, powder for - excipient ingredients: histidine hydrochloride; polysorbate 20; histidine; trehalose dihydrate - early breast cancer,indicated for the treatment of her2-positive early breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy.,locally advanced breast cancer,indicated for the treatment of her2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant therapy.,metastatic breast cancer,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,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 gastrooesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.

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

celltrion healthcare australia pty ltd - trastuzumab, quantity: 150 mg - injection, powder for - excipient ingredients: histidine hydrochloride; polysorbate 20; histidine; trehalose dihydrate - early breast cancer,indicated for the treatment of her2-positive early breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy.,locally advanced breast cancer,indicated for the treatment of her2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant therapy.,metastatic breast cancer,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,indicated in combination with cisplatin and either capecitabine or 5-fu for the treatmen

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

celltrion healthcare australia pty ltd - rituximab, quantity: 100 mg - injection, concentrated - excipient ingredients: polysorbate 80; water for injections; sodium chloride; sodium citrate dihydrate - non-hodgkin?s lymphoma truxima 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 truxima is indicated for the treatment of patients with cd20 positive chronic lymphocytic leukaemia (cll) in combination with chemotherapy.,rheumatoid arthritis truxima (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. truxima has been shown to reduce the rate of progression of joint damage as measured by xray when given in combination with methotrexate.,granulomatosis with polyangiitis (wegener?s) (gpa) and microscopic polyangiitis (mpa) truxima in combination with glucocorticoids is indicated for the induction of remission in patients with severely active granulomatosis with polyangiitis (gpa, also known as wegener?s granulomatosis) and microscopic polyangiitis (mpa). the efficacy and safety of retreatment with rituximab have not been established.

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

celltrion healthcare australia pty ltd - rituximab, quantity: 500 mg - injection, concentrated - excipient ingredients: sodium citrate dihydrate; polysorbate 80; water for injections; sodium chloride - non-hodgkin?s lymphoma truxima 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 truxima is indicated for the treatment of patients with cd20 positive chronic lymphocytic leukaemia (cll) in combination with chemotherapy.,rheumatoid arthritis truxima (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. truxima has been shown to reduce the rate of progression of joint damage as measured by xray when given in combination with methotrexate.,granulomatosis with polyangiitis (wegener?s) (gpa) and microscopic polyangiitis (mpa) truxima in combination with glucocorticoids is indicated for the induction of remission in patients with severely active granulomatosis with polyangiitis (gpa, also known as wegener?s granulomatosis) and microscopic polyangiitis (mpa). the efficacy and safety of retreatment with rituximab have not been established.

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

celltrion healthcare australia pty ltd - trastuzumab, quantity: 440 mg - injection, powder for - excipient ingredients: histidine hydrochloride; histidine; polysorbate 20; trehalose dihydrate - early breast cancer herzuma? is indicated for the treatment of her2-positive early breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy.,locally advanced breast cancer herzuma? is indicated for the treatment of her2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant herzuma?.,metastatic breast cancer herzuma? 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 postmenopausal patients with hormonereceptor positive metastatic breast cancer.,advanced gastric cancer herzuma? 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)

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.