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

ge healthcare australia pty ltd - gadoteric acid, quantity: 279.32 mg/ml - solution - excipient ingredients: meglumine; water for injections; tetraxetan - clariscan is indicated, in adults and children, for use with magnetic resonance imaging to provide contrast enhancement for intracranial and spinal lesions with abnormal blood brain barrier or abnormal vascularity, and for whole body imaging (see clinical studies).

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

ge healthcare australia pty ltd - gadoteric acid, quantity: 279.32 mg/ml - solution - excipient ingredients: meglumine; water for injections; tetraxetan - clariscan is indicated, in adults and children, for use with magnetic resonance imaging to provide contrast enhancement for intracranial and spinal lesions with abnormal blood brain barrier or abnormal vascularity, and for whole body imaging (see clinical studies).

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

medtronic australasia pty ltd - 34170 - prosthesis, internal, spine, vertebral body - the capstone control ptc spinal system is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease(ddd) at one or two levels from l2 to s1. these ddd patients may also have up to grade 1 spondylolisthesis or retrolisthesis at the involved levels. these patients should be skeleteally mature and have six months on non-operative treatment. these implants may be implanted via an open or a minimally invasive posterior approch. alternatively, these implants may also be implanted via an anterior and/or transforaminal approch. these implants are to be used with autogenous bone graft.

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

janssen-cilag pty ltd - tenofovir alafenamide, quantity: 10 mg; darunavir, quantity: 800 mg; cobicistat, quantity: 150 mg; emtricitabine, quantity: 200 mg - tablet, film coated - excipient ingredients: magnesium stearate; croscarmellose sodium; silicon dioxide; microcrystalline cellulose; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - symtuza is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults and adolescents (aged 12 years and older with body weight at least 40 kg). genotypic testing should guide the use of symtuza (see section 4.2 dose and method of administration, section 4.4 special warnings and precautions for use and section 5.1 pharmacodynamic properties).

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

avallon pharmaceuticals pty ltd - lansoprazole, quantity: 30 mg - capsule - excipient ingredients: methacrylic acid - ethyl acrylate copolymer (1:1); hypromellose; indigo carmine; colloidal anhydrous silica; titanium dioxide; maize starch; purified talc; macrogol 300; sucrose; carmoisine; gelatin; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; shellac; sulfuric acid - adults:. lanzopran capsules are indicated for. - healing and long-term management of reflux oesophagitis. . - healing and long-term management for patients with duodenal ulcer.. - healing of benign gastric ulcer. patients whose gastric or duodenal ulcer is not associated with ingestion of non-steroidal anti-inflammatory drugs require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. . - patients with benign peptic lesions that do not respond to h2-receptor antagonists.. - eradication of h. pylori from the upper gastrointestinal tract in patients with peptic ulcer or chronic gastritis when used in combination with appropriate antibiotics. . - relief of reflux-like and/or ulcer-like symptoms associated with acid-related dyspepsia. . paediatric and adolescent patients i to 17 years of age:. lanzopran capsules are indicated for. - treatment of gastro-oesophageal reflux disease, including all grades of oesophagitis. . - healing of erosive oesophagitis.

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

nuvasive (aust/nz) pty ltd - 64171 - vertebral body bone graft positioning plate - the halo buttress plate system is an anterior non-load bearing plate system that may be used in the thoracic, lumbar and sacral spine. the nuvasive halo buttress plate system, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts and autografts.

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

pharmacor pty ltd - dabigatran etexilate mesilate, quantity: 86.475 mg (equivalent: dabigatran etexilate, qty 75 mg) - capsule, hard - excipient ingredients: purified water; hypromellose phthalate; tartaric acid; butylated hydroxytoluene; hyprolose; microcrystalline cellulose; dichloromethane; purified talc; isopropyl alcohol; macrogol 600; citric acid monohydrate; ethanol; povidone; titanium dioxide; polyvinyl alcohol; macrogol 3350; sodium bicarbonate; methacrylic acid copolymer; macrogol 8000; hypromellose; sunset yellow fcf - dabigatran is indicated for prevention of venous thromboembolic events in adult patients who have undergone major orthopaedic surgery of the lower limb (elective total hip or knee replacement). prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke. treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and for the prevention of recurrent dvt and pe in adults.

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

pharmacor pty ltd - dabigatran etexilate mesilate, quantity: 86.475 mg (equivalent: dabigatran etexilate, qty 75 mg) - capsule, hard - excipient ingredients: purified water; hypromellose phthalate; hyprolose; dichloromethane; tartaric acid; ethanol; butylated hydroxytoluene; povidone; purified talc; citric acid monohydrate; isopropyl alcohol; microcrystalline cellulose; macrogol 600; titanium dioxide; polyvinyl alcohol; macrogol 3350; sodium bicarbonate; methacrylic acid copolymer; hypromellose; sunset yellow fcf; macrogol 8000 - dabigatran is indicated for prevention of venous thromboembolic events in adult patients who have undergone major orthopaedic surgery of the lower limb (elective total hip or knee replacement). prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke. treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and for the prevention of recurrent dvt and pe in adults.

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

pharmacor pty ltd - dabigatran etexilate mesilate, quantity: 86.475 mg (equivalent: dabigatran etexilate, qty 75 mg) - capsule, hard - excipient ingredients: citric acid monohydrate; butylated hydroxytoluene; dichloromethane; microcrystalline cellulose; ethanol; povidone; tartaric acid; macrogol 600; purified talc; isopropyl alcohol; hyprolose; hypromellose phthalate; purified water; titanium dioxide; hypromellose; sunset yellow fcf; macrogol 8000; polyvinyl alcohol; macrogol 3350; sodium bicarbonate; methacrylic acid copolymer - dabigatran is indicated for prevention of venous thromboembolic events in adult patients who have undergone major orthopaedic surgery of the lower limb (elective total hip or knee replacement). prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke. treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and for the prevention of recurrent dvt and pe in adults.

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

pharmacor pty ltd - dabigatran etexilate mesilate, quantity: 86.475 mg (equivalent: dabigatran etexilate, qty 75 mg) - capsule, hard - excipient ingredients: ethanol; microcrystalline cellulose; purified talc; isopropyl alcohol; dichloromethane; hypromellose phthalate; macrogol 600; butylated hydroxytoluene; povidone; citric acid monohydrate; purified water; hyprolose; tartaric acid; titanium dioxide; macrogol 8000; hypromellose; sunset yellow fcf; polyvinyl alcohol; macrogol 3350; sodium bicarbonate; methacrylic acid copolymer - dabigatran is indicated for prevention of venous thromboembolic events in adult patients who have undergone major orthopaedic surgery of the lower limb (elective total hip or knee replacement). prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke. treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and for the prevention of recurrent dvt and pe in adults.