Israel - English - Ministry of Health

alexion pharma israel ltd - eculizumab - concentrate for solution for infusion - eculizumab 10 mg/ml - eculizumab - eculizumab - soliris is indicated for the treatment of patients with: - paroxysmal nocturnal haemoglobinuria (pnh). evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history. eculizumab has not been studied in clinical trials in patients with pnh below 11 years of age.- atypical haemolytic uremic syndrome (ahus).soliris is indicated in adults for the treatment of: - refractory generalized myasthenia gravis (gmg) in patients who are anti-acetylcholine receptor (achr) antibody-positive.-neuromyelitis optica spectrum disorder (nmosd) in patients who are anti-aquaporin-4 (aqp4) antibody-positive with a relapsing course of the disease who have received prior therapy.

Israel - English - Ministry of Health

novartis israel ltd - ranibizumab - solution for injection - ranibizumab 10 mg/ml - ranibizumab - ranibizumab - treatment of patients with neovascular (wet) age-related macular degeneration (amd). treatment of adult patients with visual impairment due to diabetic macular oedema (dme) . the treatment of visual impairement due to macular oedema secondary to retinal vein occlusion (rvo). the treatment of visual impaiment due to choroidal neovascularization (cnv) . lucentis is indicated in preterm infants for: the treatment of retinopathy of prematurity (rop) with zone i (stage 1+, 2+, 3 or 3+), zone ii (stage 3+) or ap-rop (aggressive posterior rop) disease.the treatment of proliferative diabetic retinopathy (pdr)

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

ucb australia pty ltd t/a ucb pharma division of ucb australia - certolizumab pegol, quantity: 200 mg - injection, solution - excipient ingredients: sodium acetate; sodium chloride; water for injections - rheumatoid arthritis cimzia is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients. ? combined with mtx in case of either an inadequate response or intolerance to previous therapy with one or more disease modifying antirheumatic drugs (dmards) or ? as monotherapy in case of a contraindication or intolerance to mtx (see section 4.2 dose and method of administration). cimzia has been shown to reduce the rate of progression of joint damage as measured by x-ray, when given in combination with mtx. cimzia in combination with mtx is indicated for the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with mtx or other dmards.,psoriatic arthritis cimzia is indicated for the treatment of adult patients with active psoriatic arthritis where response to previous disease modifying antirheumatic drug therapy (dmards) has been inadequate. cimzia has been shown to improve physical function.,ankylosing spondylitis cimzia is indicated for the treatment of adult patients with active, ankylosing spondylitis who have been intolerant to or have had inadequate response to at least one nonsteroidal anti-inflammatory drug (nsaid).,non-radiographic axial spondyloarthritis cimzia is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axspa) with objective signs of inflammation as indicated by elevated c reactive protein (crp) and /or magnetic resonance imaging (mri) change, who have had an inadequate response to, or are intolerant to, nonsteroidal anti-inflammatory drugs (nsaids).,plaque psoriasis cimzia is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

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

boehringer ingelheim pty ltd - idarucizumab, quantity: 2500 mg - injection, solution - excipient ingredients: glacial acetic acid; polysorbate 20; sodium acetate trihydrate; sorbitol; water for injections - praxbind is a specific reversal agent for dabigatran and is indicated in patients treated with dabigatran etexilate (pradaxa) when rapid reversal of the anticoagulant effects of dabigatran is required: - for emergency surgery/urgent procedures; - in life-threatening or uncontrolled bleeding.

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

roche products pty ltd - tocilizumab, quantity: 162 mg - injection, solution - excipient ingredients: polysorbate 80; arginine; 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)

merck sharp & dohme (australia) pty ltd - pembrolizumab -

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

roche products pty ltd - trastuzumab, quantity: 600 mg - injection, solution - excipient ingredients: vorhyaluronidase alfa; histidine hydrochloride monohydrate; histidine; trehalose dihydrate; methionine; polysorbate 20; water for injections - early breast cancer: herceptin sc is indicated for the treatment of her2-positive localised breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy.,locally advanced breast cancer: herceptin sc is indicated for the treatment of her2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant herceptin.,metastatic breast cancer: herceptin sc is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress her2:,- as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease;,- in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or,- in combination with an aromatase inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer.

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

roche products pty ltd - obinutuzumab, quantity: 1000 mg - injection, concentrated - excipient ingredients: poloxamer; histidine hydrochloride monohydrate; trehalose dihydrate; water for injections; histidine - chronic lymphocytic leukaemia,gazyva in combination with chlorambucil is indicated for the treatment of patients with previously untreated chronic lymphocytic leukaemia (cll).,follicular lymphoma,gazyva in combination with chemotherapy followed by gazyva maintenance is indicated for the treatment of patients with previously untreated advanced follicular lymphoma.,gazyva in combination with bendamustine, followed by gazyva maintenance, is indicated for the treatment of patients with follicular lymphoma (fl) who did not respond to, or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.,pre-treatment to reduce the risk of cytokine release syndrome (crs) induced by glofitamab,gazyva is indicated as a pre-treatment to reduce the risk of cytokine release syndrome (crs) induced by glofitamab.

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

sanofi-aventis australia pty ltd - alemtuzumab, quantity: 10 mg/ml - injection, concentrated - excipient ingredients: disodium edetate; potassium chloride; monobasic potassium phosphate; sodium chloride; dibasic sodium phosphate heptahydrate; polysorbate 80; water for injections - lemtrada is indicated for the treatment of relapsing forms of multiple sclerosis (ms) for patients with active disease defined by clinical or imaging features to slow the accumulation of physical disability and reduce the frequency of clinical relapses.

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

roche products pty ltd - trastuzumab, quantity: 60 mg - injection, powder for - excipient ingredients: histidine hydrochloride monohydrate; polysorbate 20; trehalose dihydrate; histidine - early breast cancer. herceptin is indicated for the treatment of patients with her2 positive localised breast cancer following surgery, and in assocoation with chemotherapy and, if applicable, radiotherapy. locally advanced breast cancer.herceptin is indicated for the treatment of her2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant herceptin. metastatic breast cancer. herceptin 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 post-menopausal patients with hormone-receptor positive metastatic breast cancer. advanced gastric cancer. herceptin 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.