Australië - Engels - Department of Health (Therapeutic Goods Administration)

moderna australia pty ltd - elasomeran, quantity: 0.05 mg/ml; imelasomeran, quantity: 0.05 mg/ml - injection, suspension - excipient ingredients: heptadecan-9-yl 8-[2-hydroxyethyl-(6-oxo-6-undecoxyhexyl)amino]octanoate; water for injections; trometamol; sodium acetate trihydrate; sucrose; distearoylphosphatidylcholine; cholesterol; glacial acetic acid; 1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000; trometamol hydrochloride - spikevax bivalent original/omicron (elasomeran/imelasomeran) covid-19 vaccine has provisional approval for the indication below: as a booster dose for active immunisation to prevent coronavirus disease 2019 (covid-19) caused by sars-cov-2 in individuals 18 years of age and older. the use of this vaccine should be in accordance with official recommendations. the decision has been made on the basis of immunogenicity and short-term safety data. continued approval depends on the evidence of longer term benefits and safety from ongoing clinical trials and post-market assessment.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

moderna australia pty ltd - elasomeran, quantity: 0.05 mg/ml; davesomeran, quantity: 0.05 mg/ml - injection, suspension - excipient ingredients: 1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000; distearoylphosphatidylcholine; heptadecan-9-yl 8-[2-hydroxyethyl-(6-oxo-6-undecoxyhexyl)amino]octanoate; sucrose; trometamol; cholesterol; trometamol hydrochloride; sodium acetate trihydrate; water for injections; glacial acetic acid - spikevax bivalent original/omicron ba.4-5 (elasomeran/davesomeran) covid-19 vaccine is indicated for:,as a booster dose for active immunisation to prevent coronavirus disease 2019 (covid-19) caused by sars-cov-2 in individuals 12 years of age and older who have previously received at least a primary vaccination course against covid-19.,the use of this vaccine should be in accordance with official recommendations.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

moderna australia pty ltd - davesomeran, quantity: 0.05 mg/ml; elasomeran, quantity: 0.05 mg/ml - injection, suspension - excipient ingredients: water for injections; cholesterol; glacial acetic acid; heptadecan-9-yl 8-[2-hydroxyethyl-(6-oxo-6-undecoxyhexyl)amino]octanoate; trometamol; sucrose; distearoylphosphatidylcholine; sodium acetate trihydrate; 1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000; trometamol hydrochloride - spikevax bivalent original/omicron ba.4-5 (elasomeran/davesomeran) covid-19 vaccine is indicated for:,as a booster dose for active immunisation to prevent coronavirus disease 2019 (covid-19) caused by sars-cov-2 in individuals 12 years of age and older who have previously received at least a primary vaccination course against covid-19.,the use of this vaccine should be in accordance with official recommendations.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

moderna australia pty ltd - elasomeran, quantity: 0.05 mg/ml; davesomeran, quantity: 0.05 mg/ml - injection, suspension - excipient ingredients: 1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000; distearoylphosphatidylcholine; heptadecan-9-yl 8-[2-hydroxyethyl-(6-oxo-6-undecoxyhexyl)amino]octanoate; sucrose; trometamol; cholesterol; trometamol hydrochloride; sodium acetate trihydrate; water for injections; glacial acetic acid - spikevax bivalent original/omicron ba.4-5 (elasomeran/davesomeran) covid-19 vaccine is indicated for:,as a booster dose for active immunisation to prevent coronavirus disease 2019 (covid-19) caused by sars-cov-2 in individuals 12 years of age and older who have previously received at least a primary vaccination course against covid-19.,the use of this vaccine should be in accordance with official recommendations.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

pharmaco australia ltd - clonazepam, quantity: 2.5 mg/ml - oral liquid, solution - excipient ingredients: saccharin sodium; propylene glycol; brilliant blue fcf; glacial acetic acid; flavour - tablets. most types of epilepsy in infants and children, especially absences (petit mal), myoclonic seizures and tonic-clonic fits, whether due to primary generalised epilepsy, or to secondary generalisation of partial epilepsy. in adults all varieties of generalised epilepsy, (including myoclonic, akinetic, tonic and tonic-clonic seizures), and in partial epilepsy (including psychomotor seizures). injection. intravenous use for status epilepticus only. note. efficacy by the intramuscular route has not need demonstrated.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

viatris pty ltd - oxytocin, quantity: 5 iu/ml - injection, solution - excipient ingredients: glacial acetic acid; chlorobutanol hemihydrate; water for injections; sodium acetate trihydrate; ethanol - induction of labour; inadequate uterine effort; management of third stage of labour; post-partum haemorrhage.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

viatris pty ltd - oxytocin, quantity: 10 iu/ml - injection, solution - excipient ingredients: sodium acetate trihydrate; chlorobutanol hemihydrate; ethanol; glacial acetic acid; water for injections - induction of labour; inadequate uterine effort; management of third stage of labour; post-partum haemorrhage.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

chiesi australia pty ltd - calcitonin salmon, quantity: 50 iu/ml - injection, solution - excipient ingredients: water for injections; glacial acetic acid; sodium chloride; sodium acetate - - active paget's diseasein patients who do not respond to alternative treatments or for whom such treatments are not suitable,- hypercalcaemia.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

chiesi australia pty ltd - calcitonin salmon, quantity: 100 iu/ml - injection, solution - excipient ingredients: sodium acetate; sodium chloride; glacial acetic acid; water for injections - - active paget's diseasein patients who do not respond to alternative treatments or for whom such treatments are not suitable,- hypercalcaemia.

Nieuw-Zeeland - Engels - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - ciprofloxacin hydrochloride 2.33mg equivalent to ciprofloxacin 0.2% w/v; hydrocortisone 10mg equivalent to 1% w/v hydrocortisone;  ;  ; ciprofloxacin hydrochloride 2.33mg equivalent to ciprofloxacin 0.2% w/v; hydrocortisone 10mg equivalent to 1% w/v hydrocortisone - ear drops - active: ciprofloxacin hydrochloride 2.33mg equivalent to ciprofloxacin 0.2% w/v hydrocortisone 10mg equivalent to 1% w/v hydrocortisone     excipient: benzyl alcohol glacial acetic acid lecithin polysorbate 20 polyvinyl alcohol purified water sodium acetate trihydrate sodium chloride active: ciprofloxacin hydrochloride 2.33mg equivalent to ciprofloxacin 0.2% w/v hydrocortisone 10mg equivalent to 1% w/v hydrocortisone excipient: benzyl alcohol glacial acetic acid lecithin polysorbate 20 polyvinyl alcohol purified water sodium acetate trihydrate sodium chloride - the treatment of acute bacterial external otitis caused by organisms susceptible to the action of ciprofloxacin, including pseudomonas aeruginosa, staphylococcus aureus, acinetobacter anitratus (baumannii), stenotrophomonas maltophilia, enterobacteriaceae, enterococcus faecalis and proteus mirabilis.