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

dr reddys laboratories australia pty ltd - levetiracetam, quantity: 1000 mg - tablet, film coated - excipient ingredients: povidone; titanium dioxide; purified talc; magnesium stearate; hypromellose; silicon dioxide; macrogol 400; sodium starch glycollate type a; maize starch - 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). add-on therapy in the treatment of primary generalized tonic clonic (pgtc) seizures in adults and children from 4 years of age with idiopathic generalised epilepsy (ige).

Singapore - English - HSA (Health Sciences Authority)

abbvie pte. ltd. - palivizumab - injection, powder, for solution - 100 mg/vial (100mg/ml) - palivizumab 100 mg/vial (100mg/ml)

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

alphapharm pty ltd - levetiracetam, quantity: 1000 mg - tablet, film coated - excipient ingredients: povidone; magnesium stearate; colloidal anhydrous silica; croscarmellose sodium; maize starch; titanium dioxide; hypromellose; macrogol 6000 - 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)

arrotex pharmaceuticals pty ltd - levetiracetam, quantity: 1000 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; povidone; magnesium stearate; croscarmellose sodium; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - levi is indicated for: = 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 generalised tonic-clonic seizures (pgtc) in adults and children from 4 years of age with idiopathic generalised epilepsy (ige).

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

alphapharm pty ltd - fluconazole, quantity: 100 mg - capsule, hard - excipient ingredients: lactose monohydrate; maize starch; sodium lauryl sulfate; silicon dioxide; magnesium stearate; titanium dioxide; potable water; gelatin; patent blue v; propylene glycol; ethanol; butan-1-ol; purified water; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - treatment of cryptococcal meningitis in patients who are unable to tolerate amphotericin b. note: data suggests that the clinical efficacy of fluconazole is lower than that of amphotericin b in the treatment of acute phase cryptococcal meningitis. maintenance therapy to prevent relapse of cryptococcal meningitis in patients with acquired immune deficiency syndrome (aids). treatment of oropharyngeal and oesophageal canidiasis in aids and other immunosuppressed patients. secondary prophylaxis of oesophageal canidiasis in patients with human immunodeficiency virus (hiv) infection. serious and life-threatening candida infections in patients who are unable to tolerate amphotericin b. note: it remains to be shown that fluconazole is as effective as amphotericin b in the treatment of serious and life-threatening candida infections. until such data are available, amphotericin b remains the drug of choice. vaginal candidiasis, when topical therapy has failed. treatment of extensive tinea corporis, extensive tinea cruris and extensive tinea pedis infections in immunocompetent patients in whom topical therapy is not a practical treatment option. usually, topical therapy should be attempted first because oral therapy has a less favourable ratio of benefits to risks. (see adverse reactions).

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

arrotex pharmaceuticals pty ltd - topiramate, quantity: 100 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; sodium starch glycollate; pregelatinised maize starch; lactose; saccharin sodium; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; xanthan gum; polyvinyl alcohol; iron oxide black; lecithin; flavour - epilepsy (adults and children 2 years and over),? monotherapy in patients with newly diagnosed epilepsy,? conversion to monotherapy in patients with epilepsy,? add-on therapy in partial onset seizures (with or without secondary generalised seizures), primary generalised tonic-clonic seizures or drop attacks associated with lennox-gastaut syndrome.,migraine (adult),prophylaxis of migraine headache in adults. the usefulness of topiramate in the acute treatment of migraine headache has not been studied.

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

alphapharm pty ltd - gabapentin, quantity: 100 mg - capsule, hard - excipient ingredients: purified talc; lactose monohydrate; maize starch; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide; titanium dioxide; potable water; gelatin; sodium lauryl sulfate - gabapentin is indicated for the treatment of partial seizures, including secondarily generalised tonic-clonic seizures, initially as add-on therapy in adults and children age 3 years and above who have not achieved adequate control with standard antiepileptic drugs.,gabapentin is indicated for the treatment of neuropathic pain.

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

viatris pty ltd - temozolomide, quantity: 100 mg - capsule, hard - excipient ingredients: gelatin; titanium dioxide; purified water; colloidal anhydrous silica; tartaric acid; sodium starch glycollate; stearic acid; iron oxide red; lactose; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - treatment of newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as adjuvant treatment.,treatment of recurrence of anaplastic astrocytoma and glioblastoma multiforme following standard therapy.,temozolomide is also indicated as a first-line treatment for patients with advanced metastatic malignant melanoma.

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

laboratoires sterop sa-nv - ethanol 96 % 10 ml - concentrate for solution for infusion - ethanol 96 % 1 ml/ml - ethanol

New Zealand - English - Medsafe (Medicines Safety Authority)

actavis new zealand limited - metformin hydrochloride 1000mg;  ;   - coated tablet - 1000 mg - active: metformin hydrochloride 1000mg     excipient: magnesium stearate opadry clear oy-29020 povidone water - -treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. -metformin may be used as initial treatment or in sulfonylurea failures either alone or in combination with a sulfonylurea and other oral agents. - adjuvant therapy in insulin dependent diabetes especially if overweight.