Australia - englanti - 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 - englanti - 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.

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

interpharma pty ltd - esmolol hydrochloride, quantity: 10 mg/ml - injection, solution - excipient ingredients: sodium acetate trihydrate; glacial acetic acid; hydrochloric acid; water for injections; sodium hydroxide; sodium chloride - supraventricular tachycardia - esmolol noridem 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 noridem is also indicated in non-compensatory sinus tachycardia where, in the physician's judgement, the rapid heart rate requires specific intervention. esmolol noridem is not intended for use in chronic settings where transfer to another agent is anticipated or for treatment periods greater than 24 hours duration.

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

amdipharm mercury australia pty ltd - lanreotide acetate, quantity: 66.67 mg (equivalent: lanreotide, qty 60 mg) - injection, solution - excipient ingredients: glacial acetic acid; water for injections - mytolac is indicated for:,- the treatment of acromegaly when the circulating levels of growth hormone and igf-1 remain abnormal after surgery and/or radiotherapy or in patients who are dopamine agonist treatment refractory,- the treatment of symptoms of carcinoid syndrome associated with carcinoid tumours,- the treatment of gastroenteropancreatic neuroendocrine tumours (gep-nets) in adult patients with unresectable locally advanced or metastatic disease.

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

amdipharm mercury australia pty ltd - lanreotide acetate, quantity: 133.33 mg (equivalent: lanreotide, qty 120 mg) - injection, solution - excipient ingredients: water for injections; glacial acetic acid - mytolac is indicated for:,- the treatment of acromegaly when the circulating levels of growth hormone and igf-1 remain abnormal after surgery and/or radiotherapy or in patients who are dopamine agonist treatment refractory,- the treatment of symptoms of carcinoid syndrome associated with carcinoid tumours,- the treatment of gastroenteropancreatic neuroendocrine tumours (gep-nets) in adult patients with unresectable locally advanced or metastatic disease.

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

amdipharm mercury australia pty ltd - lanreotide acetate, quantity: 100 mg (equivalent: lanreotide, qty 90 mg) - injection, solution - excipient ingredients: water for injections; glacial acetic acid - mytolac is indicated for:,- the treatment of acromegaly when the circulating levels of growth hormone and igf-1 remain abnormal after surgery and/or radiotherapy or in patients who are dopamine agonist treatment refractory,- the treatment of symptoms of carcinoid syndrome associated with carcinoid tumours,- the treatment of gastroenteropancreatic neuroendocrine tumours (gep-nets) in adult patients with unresectable locally advanced or metastatic disease.

Euroopan unioni - englanti - EMA (European Medicines Agency)

roche registration ltd. - ibandronic acid - osteoporosis, postmenopausal - drugs for treatment of bone diseases - treatment of osteoporosis in post-menopausal women at increased risk of fracture.a reduction in the risk of vertebral fractures has been demonstrated. efficacy on femoral-neck fractures has not been established.

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

southern cross pharma pty ltd - tranexamic acid, quantity: 500 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; purified talc; colloidal anhydrous silica; povidone; vanillin; macrogol 8000; magnesium stearate; titanium dioxide; basic butylated methacrylate copolymer - oral administration hereditary angioneurotic oedema. short term use in the treatment of hyphaema and in patients with established coagulopathies who are undergoing minor surgery. menorrhagia.

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

southern cross pharma pty ltd - tranexamic acid, quantity: 500 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; colloidal anhydrous silica; purified talc; croscarmellose sodium; vanillin; povidone; macrogol 8000; titanium dioxide; magnesium stearate; basic butylated methacrylate copolymer - oral administration hereditary angioneurotic oedema. short term use in the treatment of hyphaema and in patients with established coagulopathies who are undergoing minor surgery. menorrhagia.

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

juno pharmaceuticals pty ltd - tranexamic acid, quantity: 500 mg - injection, solution - excipient ingredients: water for injections - adults for the reduction of peri? and post-operative blood loss and the need for blood transfusion in patients undergoing cardiac surgery or total knee arthroplasty or total hip arthroplasty. paediatrics for the reduction of peri? and post-operative blood loss and the need for blood transfusion in patients undergoing cardiac surgery.