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

arrotex pharmaceuticals pty ltd - levetiracetam, quantity: 250 mg - tablet, film coated - excipient ingredients: magnesium stearate; maize starch; colloidal anhydrous silica; povidone; croscarmellose sodium; titanium dioxide; hypromellose; macrogol 400; indigo carmine aluminium lake - use in epileptic patients aged 4 years and older, initially as add on therapy, in the treatment of partial onset seizures with or without secondary generalisation,,monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy.,add on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy (jme), and,add on therapy in the treatment of primary generalized tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalized epilepsy (ige).

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

southern cross pharma pty ltd - agomelatine-citric acid, quantity: 44.739 mg (equivalent: agomelatine, qty 25 mg) - tablet, film coated - excipient ingredients: mannitol; silicified microcrystalline cellulose; sodium stearylfumarate; colloidal anhydrous silica; povidone; crospovidone; magnesium stearate; stearic acid; hypromellose; macrogol 6000; titanium dioxide; purified talc; iron oxide yellow - treatment of major depression in adults including prevention of relapse.

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

servier laboratories (aust) pty ltd - agomelatine, quantity: 25 mg - tablet, film coated - excipient ingredients: magnesium stearate; povidone; stearic acid; colloidal anhydrous silica; sodium starch glycollate type a; maize starch; lactose monohydrate; propylene glycol; butan-1-ol; isopropyl alcohol; ethanol; shellac; strong ammonia solution; indigo carmine aluminium lake; glycerol; titanium dioxide; hypromellose; macrogol 6000; iron oxide yellow - treatment in adults of: - of major depression (mdd) including prevention of relapse - generalised anxiety disorder (gad)

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

southern cross pharma pty ltd - agomelatine-citric acid, quantity: 44.739 mg (equivalent: agomelatine, qty mg) - tablet, film coated - excipient ingredients: colloidal anhydrous silica; povidone; sodium stearylfumarate; mannitol; crospovidone; silicified microcrystalline cellulose; magnesium stearate; stearic acid; hypromellose; macrogol 6000; titanium dioxide; purified talc; iron oxide yellow - treatment of major depression in adults including prevention of relapse.

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

lupin australia pty limited - tenofovir disoproxil phosphate, quantity: 291 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; stearic acid; titanium dioxide; lactose monohydrate; hypromellose; triacetin; indigo carmine aluminium lake - tenofovir gh in combination with other antiretroviral agents is indicated for the treatment of hiv infected adults and paediatric patients 12 years of age and older. tenofovir gh is indicated for the treatment of chronic hepatitis b in adults (see clinical trials). tenofovir gh is indicated for the treatment of chronic hepatitis b in paediatric patients 12 years of age and older with compensated liver disease and with evidence of immune active disease, i.e. active viral replication, persistently elevated serum alt levels or evidence of active inflammation.

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

alphapharm pty ltd - losartan potassium, quantity: 25 mg - tablet, film coated - excipient ingredients: magnesium stearate; pregelatinised maize starch; lactose monohydrate; microcrystalline cellulose; titanium dioxide; hypromellose; hyprolose - hypertension: cozavan is indicated for the treatment of hypertension. it may be used alone or in combination with other antihypertensive agents (e.g. thiazide diuretics). renal protection in type 2 diabetic patients with proteinuria: cozavan is indicated to delay the progression of renal disease in hypertensive type 2 diabetics with proteinuria, defined as urinary albumin to creatinine ratio greater than or equal to 300mg/g.

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

alphapharm pty ltd - losartan potassium, quantity: 50 mg - tablet, film coated - excipient ingredients: lactose monohydrate; pregelatinised maize starch; microcrystalline cellulose; magnesium stearate; titanium dioxide; hypromellose; hyprolose - hypertension: cozavan is indicated for the treatment of hypertension. it may be used alone or in combination with other antihypertensive agents (e.g. thiazide diuretics). renal protection in type 2 diabetic patients with proteinuria: cozavan is indicated to delay the progression of renal disease in hypertensive type 2 diabetics with proteinuria, defined as urinary albumin to creatinine ratio greater than or equal to 300mg/g.

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

arrotex pharmaceuticals pty ltd - deferasirox, quantity: 90 mg - tablet, film coated - excipient ingredients: povidone; crospovidone; magnesium stearate; microcrystalline cellulose; sodium starch glycollate type a; colloidal anhydrous silica; poloxamer; titanium dioxide; indigo carmine aluminium lake; hypromellose; macrogol 4000; purified talc - the treatment of chronic iron overload due to blood transfusions (transfusional haemosiderosis) in adults and paediatric patients 6 years and older. deferasirox agh is also indicated for the treatment of chronic iron overload in paediatric patients aged 2 to 5 years who are unable to take desferrioxamine therapy or in whom desferrioxamine has proven ineffective.,deferasirox agh is also indicated for the treatment of chronic iron overload in patients with non-transfusion- dependent thalassemia syndromes aged 10 years and older.

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

arrotex pharmaceuticals pty ltd - deferasirox, quantity: 360 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; poloxamer; crospovidone; microcrystalline cellulose; magnesium stearate; povidone; sodium starch glycollate type a; titanium dioxide; indigo carmine aluminium lake; hypromellose; macrogol 4000; purified talc - the treatment of chronic iron overload due to blood transfusions (transfusional haemosiderosis) in adults and paediatric patients 6 years and older. deferasirox agh is also indicated for the treatment of chronic iron overload in paediatric patients aged 2 to 5 years who are unable to take desferrioxamine therapy or in whom desferrioxamine has proven ineffective.,deferasirox agh is also indicated for the treatment of chronic iron overload in patients with non-transfusion- dependent thalassemia syndromes aged 10 years and older.

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

arrotex pharmaceuticals pty ltd - deferasirox, quantity: 180 mg - tablet, film coated - excipient ingredients: povidone; poloxamer; sodium starch glycollate type a; microcrystalline cellulose; colloidal anhydrous silica; crospovidone; magnesium stearate; titanium dioxide; indigo carmine aluminium lake; hypromellose; macrogol 4000; purified talc - the treatment of chronic iron overload due to blood transfusions (transfusional haemosiderosis) in adults and paediatric patients 6 years and older. deferasirox agh is also indicated for the treatment of chronic iron overload in paediatric patients aged 2 to 5 years who are unable to take desferrioxamine therapy or in whom desferrioxamine has proven ineffective. ,deferasirox agh is also indicated for the treatment of chronic iron overload in patients with non-transfusion- dependent thalassemia syndromes aged 10 years and older.