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

boucher & muir pty ltd - risperidone, quantity: 1 mg/ml - oral liquid, solution - excipient ingredients: tartaric acid; benzoic acid; purified water; hydrochloric acid - rixadone is indicated for the treatment of schizophrenia and related psychoses.,rixadone is indicated for the short-term treatment of acute mania associated with bipolar 1 disorder.,rixadone is indicated for the treatment (up to 12 weeks) of psychotic symptoms, or persistent agitation or aggression unresponsive to non-pharmacological approaches in patients with moderate to severe dementia of the alzheimer type.,rixadone is indicated in the treatment of conduct and other disruptive behaviour disorders in children (over 5 years), adolescents and adults with sub-average intellectual functioning or mental retardation in whom destructive behaviours (e.g. aggression, impulsivity and self-injurious behaviours) are prominent.,rixadone is indicated for the treatment of behavioural disorders associated with autism in children and adolescents.

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

a menarini australia pty ltd - nitisinone, quantity: 4 mg - oral liquid, suspension - excipient ingredients: hypromellose; glycerol; polysorbate 80; sodium benzoate; citric acid monohydrate; sodium citrate; purified water; flavour - orfadin (nitisinone) is indicated for the treatment of patients with hereditary tyrosinaemia type 1 in combination with dietary restriction of tyrosine and phenylalanine.

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

viatris pty ltd - phenytoin, quantity: 6 mg/ml - oral liquid, suspension - excipient ingredients: sodium benzoate; polysorbate 40; citric acid monohydrate; glycerol; purified water; carmellose sodium; ethanol; vanillin; carmoisine; sucrose; sunset yellow fcf; aluminium magnesium silicate; flavour - dilantin is indicated for the control of grand mal and psychomotor seizures. dilantin will prevent or effectively decrease the incidence and severity of convulsive seizures in a high percentage of cases, with patients exhibiting little tendency to become resistant to its action. besides its effectiveness in controlling seizures, dilantin frequently improves the mental condition and outlook of epileptic patients and there is also increasing evidence that dilantin is valuable in the prevention of seizures occurring during or after neurosurgery and in the treatment of certain cardiac arrythmias. phenytoin serum level determinations may be necessary for optimal dosage adjustments (see dosage and administration).

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

glaxosmithkline australia pty ltd - rotavirus, quantity: 1000000 ccid50/dose - oral liquid, suspension - excipient ingredients: sucrose; water for injections; adipic acid; sodium hydroxide; glucose monohydrate; sodium chloride; potassium chloride; magnesium sulfate heptahydrate; ferric nitrate nonahydrate; dibasic sodium phosphate dihydrate; sodium pyruvate; folic acid; calcium pantothenate; inositol; choline chloride; nicotinamide; pyridoxine hydrochloride; thiamine hydrochloride; riboflavine; cystine; tyrosine; arginine; glycine; histidine; isoleucine; leucine; lysine; methionine; phenylalanine; threonine; tryptophan; serine; valine; glutamine; calcium chloride dihydrate; sodium bicarbonate - rotarix is indicated for the prevention of rotavirus gastroenteritis (see clinical trials).

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

glaxosmithkline australia pty ltd - rotavirus, quantity: 1000000 ccid50/dose - oral liquid, suspension - excipient ingredients: sucrose; water for injections; adipic acid; sodium hydroxide; glucose monohydrate; sodium chloride; potassium chloride; magnesium sulfate heptahydrate; ferric nitrate nonahydrate; dibasic sodium phosphate dihydrate; sodium pyruvate; folic acid; calcium pantothenate; inositol; choline chloride; nicotinamide; pyridoxine hydrochloride; thiamine hydrochloride; riboflavine; cystine; tyrosine; arginine; glycine; histidine; isoleucine; leucine; lysine; methionine; phenylalanine; threonine; tryptophan; serine; valine; glutamine; calcium chloride dihydrate; sodium bicarbonate - rotarix is indicated for the prevention of rotavirus gastroenteritis (see clinical trials).

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

lundbeck australia pty ltd - escitalopram oxalate, quantity: 25.551 mg/ml (equivalent: escitalopram, qty 20 mg/ml) - oral liquid, solution - excipient ingredients: sodium hydroxide; ethanol; purified water; propyl gallate; citric acid - treatment of major depression. treatment of social anxiety disorder (social phobia). treatment of generalised anxiety disorder. treatment of obsessive-compulsive disorder.

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

specialised therapeutics glio pty ltd - aminolevulinic acid hydrochloride, quantity: 1.5 g - oral liquid, powder for - excipient ingredients: - gliolan is indicated in adult patients for visualisation of malignant tissue during surgery for malignant gliomas that are glioblastoma multiforme (gbm) on preoperative imaging, and who are intended for resection of the tumour.

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

chiesi australia pty ltd - deferiprone, quantity: 100 mg/ml - oral liquid, solution - excipient ingredients: glycerol; hydrochloric acid; sucralose; sunset yellow fcf; peppermint oil; hyetellose; purified water; flavour - indicated for the treatment of iron overload in patients with thalassaemia major who are unable to take desferrioxamine therapy; or in whom desferrioxamine therapy has proven ineffective.

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

chiesi australia pty ltd - deferiprone, quantity: 100 mg/ml - oral liquid, solution - excipient ingredients: sucralose; purified water; glycerol; sunset yellow fcf; hydrochloric acid; hyetellose; peppermint oil; flavour - indicated for the treatment of iron overload in patients with thalassaemia major who are unable to take desferrioxamine therapy; or in whom desferrioxamine therapy has proven ineffective.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

pinewood healthcare - fluoxetine hydrochloride - oral solution - 4mg/1ml