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

novartis pharmaceuticals australia pty ltd - carbamazepine, quantity: 200 mg - tablet, uncoated - excipient ingredients: carmellose sodium; magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica - 1. epilepsy: complex or simple partial seizures (with or without loss of consciousness) with or without secondary generalisation; generalised tonic-clonic seizures; mixed seizure patterns incorporating the above. tegretol is suitable for monotherapy and combination therapy. tegretol is usually not effective in absence seizures, atonic seizures and myoclonic seizures and should not be used for status epilepticus (see "precautions"). 2. trigeminal neuralgia: for relief of pain in idiopathic trigeminal neuralgia and trigeminal neuralgia due to multiple sclerosis; and in idiopathic glossopharyngeal neuralgia. (tegretol is not a simple analgesic and is not intended for trivial facial pain or headache). 3. mania and bipolar affective disorders: treatment of mania and maintenance treatment of bipolar affective disorders to prevent or attenuate recurrence.

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

novartis pharmaceuticals australia pty ltd - carbamazepine, quantity: 100 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; carmellose sodium - 1. epilepsy: complex or simple partial seizures (with or without loss of consciousness) with or without secondary generalisation; generalised tonic-clonic seizures; mixed seizure patterns incorporating the above. tegretol is suitable for monotherapy and combination therapy. tegretol is usually not effective in absence seizures, atonic seizures and myoclonic seizures and should not be used for status epilepticus (see "precautions"). 2. trigeminal neuralgia: for relief of pain in idiopathic trigeminal neuralgia and trigeminal neuralgia due to multiple sclerosis; and in idiopathic glossopharyngeal neuralgia. (tegretol is not a simple analgesic and is not intended for trivial facial pain or headache). 3. mania and bipolar affective disorders: treatment of mania and maintenance treatment of bipolar affective disorders to prevent or attenuate recurrence.

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

lupin australia pty limited - ethinylestradiol, quantity: 30 microgram; drospirenone, quantity: 3 mg - tablet - excipient ingredients: maize starch; magnesium stearate; pregelatinised maize starch; lactose monohydrate; titanium dioxide; hypromellose; macrogol 400 - for use as an oral contraceptive

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

glaxosmithkline australia pty ltd - atovaquone, quantity: 62.5 mg; proguanil hydrochloride, quantity: 25 mg - tablet, film coated - excipient ingredients: sodium starch glycollate; magnesium stearate; hypromellose; macrogol 8000; microcrystalline cellulose; titanium dioxide; poloxamer; hyprolose; povidone; macrogol 400; iron oxide red - prophylaxis of plasmodium falciparum malaria in adults and children 11kg and over; treatment of plasmodium falciparum malaria in adults and children aged 3 years or older.

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

glaxosmithkline australia pty ltd - atovaquone, quantity: 250 mg; proguanil hydrochloride, quantity: 100 mg - tablet, film coated - excipient ingredients: poloxamer; hyprolose; hypromellose; macrogol 400; magnesium stearate; microcrystalline cellulose; sodium starch glycollate; titanium dioxide; macrogol 8000; iron oxide red; povidone - malarone is indicated for the treatment of plasmodium falciparum malaria in adults and children aged 3 years or older. indications as at 1 november 2001: "prophylaxis of plasmodium falciparum malaria in individuals weighing >40kg". this approval is based on the evaluation of the information and data provided with the original letter of application and with any subsequent correspondence and submissions relating to the application. indications as at 13 january 2003: prophylaxis of plasmodium falciparum malaria in adults and children 11kg and over; treatment of plasmodium falciparum malaria in adults and children aged 3 years or older.

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

dr reddys laboratories australia pty ltd - calcium carbonate, quantity: 1.25 g (equivalent: calcium, qty 500 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; crospovidone; croscarmellose sodium; povidone; magnesium stearate; hypromellose; macrogol 8000; chlorophyllin-copper complex; titanium dioxide; carnauba wax - for the treatment of: ? osteoporosis in select patients where vitamin d and calcium supplementation is recommended,prior to treatment, osteoporosis must be confirmed by: ? the finding of low bone mass of at least 2 standard deviations below the gender specific mean for young adults or by ? the presence of osteoporotic fracture

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

viiv healthcare pty ltd - cabotegravir, quantity: 30 mg (equivalent: cabotegravir sodium, qty mg) - tablet, film coated - excipient ingredients: titanium dioxide; magnesium stearate; hypromellose; lactose monohydrate; microcrystalline cellulose; sodium starch glycollate type a; macrogol 3350 - vocabria tablets are indicated in combination with rilpivirine tablets for the short-term treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults who are virologically suppressed (hiv-1 rna <50 copies/ml) and have no known or suspected resistance to either cabotegravir or rilpivirine (see sections 4.2 dose and method of administration and 5.1 pharmacodynamic properties, clinical trials) for: ? oral lead in to assess tolerability of cabotegravir prior to administration of cabotegravir prolonged-release suspension for injection plus rilpivirine prolonged-release suspension for injection. ? oral therapy for adults who will miss planned dosing with cabotegravir prolonged-release suspension for injection.

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

arrotex pharmaceuticals pty ltd - amlodipine besilate, quantity: 6.9335 mg (equivalent: amlodipine, qty 5 mg) - tablet, uncoated - excipient ingredients: mannitol; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; sodium starch glycollate - hypertension: amlo 5 tablets are indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine, which has been used in combination with a thiazide diuretic, beta adrenoreceptor blocking agent or an angiotensin-converting enzyme inhibitor. angina: amlo 5 tablets are indicated for the first line treatment of chronic stable angina. amlo 5 tablets may be used alone, as monotherapy or in combination with other antianginal drugs.

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

alphapharm pty ltd - voriconazole, quantity: 200 mg - tablet, film coated - excipient ingredients: lactose monohydrate; croscarmellose sodium; pregelatinised maize starch; povidone; magnesium stearate; titanium dioxide; hypromellose; triacetin - vttack is indicated for treatment of the following fungal infections: invasive aspergillosis. serious candida infections (including c. krusei), including oesophageal and systemic candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia). serious fungal infections caused by scedosporium spp and fusarium spp. other serious fungal infections, in patients intolerant of, or refractory to, other therapy. prophylaxis in patients who are at high risk of developing invasive fungal infections. the indication is based on studies including patients undergoing haematopoietic stem cell transplantation. this brand is only available as tablets and therefore only indicated for adults and children 12 years or older who can tolerate tablets. for dosing requirements for populations who require intravenous or oral suspension treatment see dosage and administration

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

alphapharm pty ltd - voriconazole, quantity: 50 mg - tablet, film coated - excipient ingredients: lactose monohydrate; croscarmellose sodium; pregelatinised maize starch; povidone; magnesium stearate; titanium dioxide; hypromellose; triacetin - vttack is indicated for treatment of the following fungal infections: invasive aspergillosis. serious candida infections (including c. krusei), including oesophageal and systemic candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia). serious fungal infections caused by scedosporium spp and fusarium spp. other serious fungal infections, in patients intolerant of, or refractory to, other therapy. prophylaxis in patients who are at high risk of developing invasive fungal infections. the indication is based on studies including patients undergoing haematopoietic stem cell transplantation. this brand is only available as tablets and therefore only indicated for adults and children 12 years or older who can tolerate tablets. for dosing requirements for populations who require intravenous or oral suspension treatment see dosage and administration