Australien - engelsk - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - risperidone, quantity: 1 mg/ml - oral liquid, solution - excipient ingredients: purified water; benzoic acid; tartaric acid; sodium hydroxide - risperdal is indicated for the treatment of schizophrenia and related psychoses. risperdal is indicated for the short term treatment of acute mania associated with bipolar 1 disorder. risperdal is also indicated for the treatment of behavioural disturbances in dementia. risperdal 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 (see clinical trials for maintenance data). risperdal is indicated for the treatment of behavioural disorders associated with autism in children and adolescents (see clinical trials).

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - amisulpride, quantity: 100 mg/ml - oral liquid, solution - excipient ingredients: methyl hydroxybenzoate; hydrochloric acid; propyl hydroxybenzoate; purified water; potassium sorbate; saccharin sodium; gluconolactone; sodium gluconate; flavour - amisulpride is indicated for the treatment of acute and chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as blunted affect, emotional and social withdrawal) are prominent, including patients characterised by predominant negative symptoms.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

phebra pty ltd - caffeine, quantity: 12.5 mg - oral liquid, solution - excipient ingredients: citric acid monohydrate; sodium citrate dihydrate; water for injections - cafnea oral solution is indicated for the short-term treatment of apnoea of prematurity in infants between 28 and 33 weeks gestational age.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

ucb australia pty ltd t/a ucb pharma division of ucb australia - levetiracetam, quantity: 100 mg/ml - oral liquid, solution - excipient ingredients: acesulfame potassium; purified water; maltitol solution; methyl hydroxybenzoate; ammonium glycyrrhizinate; citric acid monohydrate; propyl hydroxybenzoate; sodium citrate dihydrate; glycerol; flavour - keppra (film coated tablets and oral solution) 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 in adults and children from 4 years of age with idiopathic generalised epilepsy (ige). keppra concentrate solution for iv infusion after dilution is an alternative for patients when oral administration is temporarily not feasible.

Malta - engelsk - Medicines Authority

menarini international operations luxembourg s.a 1 avenue de la gare, l-1611, luxembourg - tramadol hydrochloride, dexketoprofen trometamol - granules for oral solution - tramadol hydrochloride 75 mg dexketoprofen trometamol 25 mg - analgesics

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

strides pharma science pty ltd - levetiracetam, quantity: 100 mg/ml - oral liquid, solution - excipient ingredients: maltitol solution; purified water; citric acid monohydrate; glycerol; methyl hydroxybenzoate; propylene glycol; sodium citrate dihydrate; acesulfame potassium; propyl hydroxybenzoate; ammonium glycyrrhizinate; flavour - 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).

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

aft pharmaceuticals pty ltd - levetiracetam, quantity: 10 % w/v - oral liquid, solution - excipient ingredients: acesulfame potassium; propyl hydroxybenzoate; purified water; maltitol solution; glycerol; sodium citrate dihydrate; methyl hydroxybenzoate; ammonium glycyrrhizinate; citric acid monohydrate; flavour - levetiracetam-aft oral solution 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 generalized tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalized epilepsy (ige).,levetiracetam-aft concentrate solution for iv infusion after dilution is an alternative for patients when oral administration is temporarily not feasible.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

abbvie pty ltd - lopinavir, quantity: 80 mg/ml; ritonavir, quantity: 20 mg/ml - oral liquid, solution - excipient ingredients: ethanol absolute; glycerol; acesulfame potassium; sodium chloride; menthol; high fructose maize syrup; saccharin sodium; purified water; povidone; peg-40 hydrogenated castor oil; peppermint oil; propylene glycol; citric acid; sodium citrate dihydrate; flavour - kaletra is indicated for the treatment of hiv-1 infection, in combination with other antiretroviral agents in adults and children aged 2 years and older. this indication is based on the analyses of plasma hiv-1 rna levels and cd4 cell counts from controlled clinical studies (see clinical trials).

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - posaconazole, quantity: 40 mg/ml - oral liquid, suspension - excipient ingredients: sodium benzoate; sodium citrate dihydrate; citric acid monohydrate; titanium dioxide; glycerol; xanthan gum; liquid glucose; peg-40 hydrogenated castor oil; purified water; peg-40 stearate; benzoic acid; glyceryl monostearate; methylcellulose; polysorbate 65; simethicone; sorbic acid; sulfuric acid; flavour - posaconazole is indicated for use in the treatment of the following invasive fungal infections in patients 13 years of age or older: ? invasive aspergillosis in patients intolerant of, or with disease that is refractory to, alternative therapy. ? fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, and mycetoma in patients intolerant of, or with disease that is refractory to, alternative therapy.,posaconazole is also indicated for the: ? treatment of oropharyngeal candidiasis in immunocompromised adults, including patients with disease that is refractory to itraconazole and fluconazole. ? prophylaxis of invasive fungal infections among patients 13 years of age and older, who are at high risk of developing these infections, such as patients with prolonged neutropenia or haematopoietic stem cell transplant (hsct) recipients.

Irland - engelsk - HPRA (Health Products Regulatory Authority)

menarini international operations luxembourg s.a. - tramadol hydrochloride; dexketoprofen - granules for oral solution in sachet - 75mg/25 milligram(s) - opioids in combination with non-opioid analgesics; tramadol and dexketoprofen