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

janssen-cilag pty ltd - teclistamab, quantity: 30 mg - injection, solution - excipient ingredients: glacial acetic acid; sucrose; disodium edetate; sodium acetate trihydrate; polysorbate 20; water for injections - tecvayli as monotherapy has provisional approval in australia and is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-cd38 monoclonal antibody.,the decision to approve this indication has been made on the basis of the overall response rate in a single arm study. continued approval of this indication depends on verification and description of benefit in confirmatory trials.

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

janssen-cilag pty ltd - teclistamab, quantity: 153 mg - injection, solution - excipient ingredients: polysorbate 20; sodium acetate trihydrate; glacial acetic acid; sucrose; water for injections; disodium edetate - tecvayli as monotherapy has provisional approval in australia and is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-cd38 monoclonal antibody.,the decision to approve this indication has been made on the basis of the overall response rate in a single arm study. continued approval of this indication depends on verification and description of benefit in confirmatory trials.

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

medsurge pharma pty ltd - esmolol hydrochloride, quantity: 100 mg - injection, solution - excipient ingredients: glacial acetic acid; sodium acetate trihydrate; sodium chloride; sodium hydroxide; hydrochloric acid; water for injections - esmolol hydrochloride medsurge is indicated for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of ventricular rate with a short-acting agent is desirable. esmolol hydrochloride medsurge is also indicated in non-compensatory sinus tachycardia where, in the physician?s judgement, the rapid heart rate requires specific intervention. esmolol hydrochloride medsurge is not intended for use in chronic settings where transfer to another agent is anticipated or for treatment periods greater than 24 hours duration.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmaco (nz) ltd - carbetocin 100ug; carbetocin 100 µg/ml - solution for injection - 100 mcg - active: carbetocin 100ug excipient: glacial acetic acid sodium chloride water for injection active: carbetocin 100 µg/ml excipient: mannitol methionine sodium hydroxide succinic acid water for injection - duratocin is indicated for the prevention of uterine atony and excessive bleeding following delivery of the infant by elective caesarean section under epidural or spinal anaesthesia.

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

juno pharmaceuticals pty ltd - tropisetron hydrochloride, quantity: 2.26 mg (equivalent: tropisetron, qty 2 mg) - injection, solution - excipient ingredients: sodium chloride; water for injections; glacial acetic acid; sodium acetate trihydrate - for the treatment and prevention of post-operative nausea and vomiting in adults (2 mg/2 ml ampoule only)

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

novartis pharmaceuticals australia pty ltd - hydrocortisone, quantity: 10 mg/ml; ciprofloxacin, quantity: 2 mg/ml - ear drops, suspension - excipient ingredients: polysorbate 20; sodium acetate; glacial acetic acid; benzyl alcohol; hydrogenated soy phosphatidylcholine; sodium chloride; polyvinyl alcohol; purified water - for the treatment of acute bacterial otitis externa, caused by organisms susceptible to ciprofloxacin (see pharmacology), in adults and children aged 2 years and older.

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

haleon australia pty ltd - isopropyl alcohol, quantity: 634 mg/ml; glacial acetic acid, quantity: 17.3 mg/ml - ear drops, solution - excipient ingredients: purified water - helps prevent and helps treat swimmer's ear the painful ear infection that often occurs when water is trapped in the ear canal after swimming, bathing, surfing or diving. aquaear dries up moisture and retards the growth of bacteria. aquaear also helps relieve the painful inflammation caused by swimmer's ear.

Australia - English - 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.

Australia - English - 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.

Australia - English - 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.