Australia - Inggeris - 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 - Inggeris - 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.

Ireland - Inggeris - HPRA (Health Products Regulatory Authority)

wockhardt uk limited - dexamethasone sodium phosphate - solution for injection/infusion - 4 milligram(s)/millilitre - glucocorticoids; dexamethasone - glucocorticoids - it e can be used for all forms of general and local glucocorticoid injection therapy and all acute conditions in which intravenous glucocorticoids may be life-saving.

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

sandoz pty ltd - ropivacaine hydrochloride, quantity: 2 mg/ml - injection, solution - excipient ingredients: water for injections; sodium hydroxide; hydrochloric acid; sodium chloride - surgical anaesthesia (adults and children over 12 years of age). - epidural block for surgery including caesarean section. - intrathecal anaesthesia. - field block (minor nerve block and infiltration). - major nerve block. analgesia (adults and children over 12 years of age). - continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain. - field block (minor nerve block and infiltration). - continuous peripheral nerve block infusion or intermittent injections for post operative pain management. analgesia (children aged 0 - 12 years). - caudal epidural block in neonates (> 37 weeks gestation and over 2500 g weight), infants and children up to and including 12 years . - continuous epidural infusion in infants (> 30 days and over 2500 g weight) and children up to and including 12 years. - peripheral nerve block in children aged 1 up to and including 12 years. for peri- and postoperative pain management. there are no safety or efficacy data to support the use of ropivacaine for analgesia for longer than 72 hours. (data for peripheral nerve block administered as a continuous peripheral infusion or intermittent injections support the use for up to 48 hours only).

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

sandoz pty ltd - ropivacaine hydrochloride, quantity: 5 mg/ml - injection, solution - excipient ingredients: water for injections; sodium chloride; hydrochloric acid; sodium hydroxide - surgical anaesthesia (adults and children over 12 years of age). - epidural block for surgery including caesarean section. - intrathecal anaesthesia. - field block (minor nerve block and infiltration). - major nerve block. analgesia (adults and children over 12 years of age). - continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain. - field block (minor nerve block and infiltration). - continuous peripheral nerve block infusion or intermittent injections for post operative pain management. analgesia (children aged 0 - 12 years). - caudal epidural block in neonates (> 37 weeks gestation and over 2500 g weight), infants and children up to and including 12 years . - continuous epidural infusion in infants (> 30 days and over 2500 g weight) and children up to and including 12 years. - peripheral nerve block in children aged 1 up to and including 12 years. for peri- and postoperative pain management. there are no safety or efficacy data to support the use of ropivacaine for analgesia for longer than 72 hours. (data for peripheral nerve block administered as a continuous peripheral infusion or intermittent injections support the use for up to 48 hours only).

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

sandoz pty ltd - ropivacaine hydrochloride, quantity: 5 mg/ml - injection, solution - excipient ingredients: hydrochloric acid; sodium chloride; sodium hydroxide; water for injections - surgical anaesthesia (adults and children over 12 years of age). - epidural block for surgery including caesarean section. - intrathecal anaesthesia. - field block (minor nerve block and infiltration). - major nerve block. analgesia (adults and children over 12 years of age). - continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain. - field block (minor nerve block and infiltration). - continuous peripheral nerve block infusion or intermittent injections for post operative pain management. analgesia (children aged 0 - 12 years). - caudal epidural block in neonates (> 37 weeks gestation and over 2500 g weight), infants and children up to and including 12 years . - continuous epidural infusion in infants (> 30 days and over 2500 g weight) and children up to and including 12 years. - peripheral nerve block in children aged 1 up to and including 12 years. for peri- and postoperative pain management. there are no safety or efficacy data to support the use of ropivacaine for analgesia for longer than 72 hours. (data for peripheral nerve block administered as a continuous peripheral infusion or intermittent injections support the use for up to 48 hours only).

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

bayer australia ltd - iopromide, quantity: 768.86 mg/ml - injection, solution - excipient ingredients: dilute hydrochloric acid; sodium calcium edetate; trometamol; water for injections; sodium hydroxide - ultravist is indicated for all angiographic and urographic examinations and for contrast enhancement in computerised tomography.,ultravist 300 or 370 is indicated for use in contrast-enhanced mammography (cem) in adults, to visualise known or suspected lesions of the breast as an adjunct to mammography (with or without ultrasound).

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

southern xp ip pty ltd - sodium nitroprusside, quantity: 25 mg/ml - injection, concentrated - excipient ingredients: water for injections - nitroprusside sxp concentrated injection is indicated for:,1. immediate reduction of blood pressure in patients with hypertensive crises. concomitant oral antihypertensive medication should be started while the hypertensive emergency is being brought under control with sodium nitroprusside.,2. producing controlled hypotension during anaesthesia in order to reduce bleeding in surgical procedures where surgeon and anaesthetist deem it appropriate.,3. short term therapy of cardiac failure, to enhance cardiac output and lower myocardial oxygen requirements. patients should be commenced on oral therapy as soon as possible.

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

emcure pharmaceuticals pty ltd - sodium nitroprusside, quantity: 50 mg - injection, concentrated - excipient ingredients: water for injections - sodium nitroprusside concentrated injection is indicated for: ,1. immediate reduction of blood pressure in patients with hypertensive crises. concomitant oral antihypertensive medication should be started while the hypertensive emergency is being brought under control with sodium nitroprusside. ,2. producing controlled hypotension during anaesthesia in order to reduce bleeding in surgical procedures where surgeon and anaesthetist deem it appropriate. ,3. short term therapy of cardiac failure, to enhance cardiac output and lower myocardial oxygen requirements. patients should be commenced on oral therapy as soon as possible.

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

fresenius kabi australia pty ltd - ropivacaine hydrochloride, quantity: 200 mg - injection, solution - excipient ingredients: sodium chloride; hydrochloric acid; sodium hydroxide; water for injections - surgical anaesthesia (adults and children over 12 years of age); epidural block for surgery including caesarean section; intrathecal anaesthesia; field block (minor nerve block and infiltration); major nerve block. analgesia (adults and children over 12 years of age); continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain; field block (minor nerve block and infiltration); continuous peripheral nerve block infusion or intermittent injections for post operative pain management; continuous wound infusion for postoperative pain management (adults only). analgesia (children aged 0 - 12 years); caudal epidural block in neonates (> 37 weeks gestation and over 2500 g weight), infants and children up to and including 12 years. continous epidural infusion in infants (> 30 days and over 2500 g weight) and children up to and including 12 years; peripheral nerve block in children aged 1 up to and including 12 years. for peri- and postoperative pain management. there are no safety or efficacy data to support the use of ropivacaine hydrochloride for analgesia for longer than 72 hours. (data for peripheral nerve block administered as a continuous peripheral infusion or intermittent injections and for continuous wound infusion support the use for up to 48 hours only).