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

alphapharm pty ltd - metformin hydrochloride, quantity: 850 mg - tablet, film coated - excipient ingredients: hypromellose; magnesium stearate; povidone - metformin is indicated for the treatment of type 2 diabetes mellitus in adults, children from 10 years of age and adolescents, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. for adult patients, metformin may be used as initial treatment or in sulfonylurea failures either alone or in combination with a sulfonylurea and other oral agents or as adjuvant therapy in insulin requiring type 2 diabetes.

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

alphapharm pty ltd - metformin hydrochloride, quantity: 500 mg - tablet, film coated - excipient ingredients: hypromellose; povidone; magnesium stearate - metformin is indicated for the treatment of type 2 diabetes mellitus in adults, children from 10 years of age and adolescents, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. for adult patients, metformin may be used as initial treatment or in sulfonylurea failures either alone or in combination with a sulfonylurea and other oral agents or as adjuvant therapy in insulin requiring type 2 diabetes.

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

generic health pty ltd - raloxifene hydrochloride, quantity: 60 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; poloxamer; calcium hydrogen phosphate dihydrate; citric acid monohydrate; sodium starch glycollate; magnesium stearate; titanium dioxide; lactose monohydrate; hypromellose; macrogol 4000 - raloxifene gh is proposed to be used for:,1. the prevention and treatment of osteoprosis in post-menopausal women,2. the reduction in the risk of invasive breast cancer in postmenopausal women with osteoporosis,3. the reduction in the risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer,high risk of breast cancer is defined as at least one breast biopsy showing lobular carcinoma in situ (lcis) or atypical hyperplasia, one or more first-degree relatives with breast cancer, or a 5-year predicted risk of breast cancer >1.66% (based on the modified gail model). among the factors included in the modified gail model are the following: current age, number of first-degree relatives with breast cancer, number of breast biopsies, age at menarche, nulliparity or age of first live birth. currently, no single clinical finding or test result can quantify risk of breast cancer with certainty.

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

eli lilly australia pty ltd - raloxifene hydrochloride, quantity: 60 mg - tablet, film coated - excipient ingredients: crospovidone; polysorbate 80; magnesium stearate; lactose monohydrate; lactose; povidone; carnauba wax; colour; propylene glycol; indigo carmine; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; industrial methylated spirit; ethanol - evista is indicated for the prevention and treatment of osteoporosis in post-menopausal women. evista is indicated for the reduction in the risk of invasive breast cancer in postmenopausal women with osteoporosis. evista is indicated for the reduction in the risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer. high risk of breast cancer is defined as at least one breast biopsy showing lobular carcinoma in situ (lcis) or atypical hyperplasia, one or more first-degree relatives with breast cancer, or a 5-year predicted risk of breast cancer >1.66% (based on the modified gail model). among the factors included in the modified gail model are the following: current age, number of first-degree relatives with breast cancer, number of breast biopsies, age at menarche, nulliparity or age of first live birth. currently, no single clinical finding or test result can quantify risk of breast cancer with certainty.

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

sandoz pty ltd - zoledronic acid monohydrate, quantity: 5.33 mg (equivalent: zoledronic acid, qty 5 mg) - injection, solution - excipient ingredients: mannitol; sodium citrate dihydrate; water for injections - - treatment of osteoporosis in postmenopausal women to reduce the incidence of hip, vertebral and non-vertebral fractures. - treatment of osteoporosis in patients over 50 years of age with a history of at least one low trauma hip fracture, to reduce the incidence of further fractures. - to increase bone mineral density in men with osteoporosis. - to increase bone mineral density in patients with osteoporosis associated with long term glucocorticoid use. - to prevent glucocorticiod-induced bone mineral density loss. - treatment of paget's disease of bone.

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

sandoz pty ltd - zoledronic acid monohydrate, quantity: 5.33 mg (equivalent: zoledronic acid, qty 5 mg) - injection, solution - excipient ingredients: mannitol; sodium citrate dihydrate; water for injections - - treatment of osteoporosis in postmenopausal women to reduce the incidence of hip, vertebral and non-vertebral fractures. - treatment of osteoporosis in patients over 50 years of age with a history of at least one low trauma hip fracture, to reduce the incidence of further fractures. - to increase bone mineral density in men with osteoporosis. - to increase bone mineral density in patients with osteoporosis associated with long term glucocorticoid use. - to prevent glucocorticiod-induced bone mineral density loss. - treatment of paget's disease of bone.

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

merck sharp & dohme (australia) pty ltd - hpv type 6 l1 protein, quantity: 20 microgram; hpv type 11 l1 protein, quantity: 40 microgram; hpv type 16 l1 protein, quantity: 40 microgram; hpv type 18 l1 protein, quantity: 20 microgram - injection, suspension - excipient ingredients: aluminium; histidine; polysorbate 80; borax; water for injections; sodium chloride - gardasil is indicated in females aged 9 through 45 years* for the prevention of cervical, vulvar, vaginal and anal cancer, precancerous or dysplastic lesions, genital warts, and infection caused by human papillomavirus (hpv) types 6, 11, 16, and 18 (which are included in the vaccine). gardasil is indicated in males 9 through 26 years of age for the prevention of anal cancer, precancerous or dysplastic lesions, external genital lesions and infection caused by hpv types 6, 11, 16, and 18 (which are included in the vaccine). *immunogenicity studies have been conducted to link efficacy in females and males aged 16 to 26 years to the younger populations.

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

swedish orphan biovitrum pty ltd - anakinra, quantity: 100 mg - injection, solution - excipient ingredients: polysorbate 80; sodium citrate dihydrate; water for injections; disodium edetate; sodium chloride - kineret (anakinra) is indicated: -for the treatment of active adult rheumatoid arthritis (ra) in patients who have had inadequate response to one or more other disease modifying anti rheumatic drugs (dmards). kineret should be given in combination with methotrexate. - in adult and paediatric patients aged 8 months and older with a body weight of 10 kg or above for the treatment of cryopyrin-associated periodic syndromes (caps) including neonatal-onset multisystem inflammatory disease (nomid) / chronic infantile neurological, cutaneous, articular syndrome (cinca), muckle-wells syndrome (mws), and familial cold autoinflammatory syndrome (fcas). - for the treatment of active systemic juvenile idiopathic arthritis (sjia) in patients 2 years and above who have failed to respond adequately to non-biological dmards

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

janssen-cilag pty ltd - infliximab, quantity: 100 mg - injection, powder for - excipient ingredients: dibasic sodium phosphate dihydrate; monobasic sodium phosphate monohydrate; polysorbate 80; sucrose - rheumatoid arthritis in adults: remicade, 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. remicade should be given in combination with methotrexate. efficacy and safety in rheumatoid arthritis have been demonstrated only in combination with methotrexate. ankylosing spondylitis: remicade is indicated for the reduction of signs and symptoms and improvement in physical function in patients with active disease. psoriatic arthritis: remicade 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. remicade may be administered in combination with methotrexate. psoriasis: remicade 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 and in children and adolescents (6-17 years): remicade 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: remicade is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients. ulcerative colitis in adults and in children and adolescents (6 to 17 years); remicade is 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)

maxx pharma pty ltd - eslicarbazepine acetate, quantity: 800 mg - tablet, uncoated - excipient ingredients: magnesium stearate; croscarmellose sodium; povidone - zebinix is indicated as:,? monotherapy in the treatment of partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy;,? adjunctive therapy in adults, adolescents and children aged above 6 years, with partial-onset seizures with or without secondary generalisation.