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

bayer australia ltd - ethinylestradiol, quantity: 20 microgram; drospirenone, quantity: 3 mg - tablet, uncoated - excipient ingredients: magnesium stearate; titanium dioxide; lactose monohydrate; hypromellose; purified talc; microcrystalline cellulose - yaz is indicated for use as: - an oral contraceptive. - treatment of moderate acne vulgaris in women who seek oral contraception - treatment of symptoms of premenstrual dysphoric disorder (pmdd) in women who have chosen oral contraceptives as their method of birth control. the efficacy of yaz for pmdd was not assessed beyond 3 cycles. yaz has not been evaluated for treatment of pms (premenstrual syndrome), see clinical trials.

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

glaxosmithkline australia pty ltd - hpv type 16 l1 protein, quantity: 20 microgram; hpv type 18 l1 protein, quantity: 20 microgram - injection, suspension - excipient ingredients: monobasic sodium phosphate; aluminium hydroxide hydrate; water for injections; 3-o-desacyl-4'-monophosphoryl lipid a; sodium chloride - cervarix is indicated in females from 10 to 45 years of age for the prevention of persistent infection, premalignant cervical lesions and cervical cancer caused by human papillomavirus types 16 and 18. lmmunogenicity studies have been conducted in females aged 10 to 14 years and 26 to 45 years to link efficacy in females aged 15 to 25 years to other populations (see precautions and clinical trials).

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

roche products pty ltd - imdevimab, quantity: 120 mg/ml - injection, solution - excipient ingredients: histidine; histidine hydrochloride monohydrate; sucrose; polysorbate 80; water for injections - ronapreve has provisional approval for the indications below:,treatment:,ronapreve is indicated for the treatment of covid-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg) who do not require supplemental oxygen for covid-19 and who are at increased risk of progressing to severe covid-19.,post-exposure prophylaxis:,ronapreve is indicated for the prevention of covid-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg) who have been exposed to sars-cov-2 and who either:,? have a medical condition making them unlikely to respond to or be protected by vaccination, or,? are not vaccinated against covid-19. (,refer to section 4.2 dose and method of administration and section 5.1, clinical trials),ronapreve is not intended to be used as a substitute for vaccination against covid-19.,the decision has been made on the basis of short term efficacy and safety data. continued approval of this indication depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.,the use of ronapreve should take into account information on the activity of ronapreve against viral variants of concern. see sections 4.4 and 5.1.

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

roche products pty ltd - imdevimab, quantity: 120 mg/ml - injection, solution - excipient ingredients: histidine; histidine hydrochloride monohydrate; sucrose; polysorbate 80; water for injections - ronapreve has provisional approval for the indications below:,treatment:,ronapreve is indicated for the treatment of covid-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg) who do not require supplemental oxygen for covid-19 and who are at increased risk of progressing to severe covid-19.,post-exposure prophylaxis:,ronapreve is indicated for the prevention of covid-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg) who have been exposed to sars-cov-2 and who either:,? have a medical condition making them unlikely to respond to or be protected by vaccination, or,? are not vaccinated against covid-19.,(refer to section 4.2 dose and method of administration and 5.1, clinical trials),ronapreve is not intended to be used as a substitute for vaccination against covid-19.,the decision has been made on the basis of short term efficacy and safety data. continued approval of this indication depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.,the use of ronapreve should take into account information on the activity of ronapreve against viral variants of concern. see sections 4.4 and 5.1.

Australia - English - 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.

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

astrazeneca pty ltd - chadox1-s, quantity: 100000000000 vp/ml - injection, solution - excipient ingredients: histidine; magnesium chloride hexahydrate; sucrose; disodium edetate; polysorbate 80; sodium chloride; histidine hydrochloride monohydrate; ethanol absolute; water for injections - vaxzevria has provisional approval for the indication:,active immunisation of individuals greater than or equal to 18 years old for the prevention of coronavirus disease 2019 (covid-19) caused by sars-cov-2.,the use of this vaccine should be in accordance with official recommendations.,the decision has been made on the basis of short term efficacy and safety data. continued approval is dependent upon the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.

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

janssen-cilag pty ltd - ad26.cov2.s, quantity: 50000000000 vp - injection, suspension - excipient ingredients: sodium chloride; polysorbate 80; sodium hydroxide; hydroxypropylbetadex; citric acid monohydrate; sodium citrate dihydrate; ethanol absolute; hydrochloric acid; water for injections - covid-19 vaccine janssen has provisional approval for the indication:,covid-19 vaccine janssen is indicated for active immunisation to prevent 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 short term efficacy and safety data. continued approval is dependent upon the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.

Australia - English - 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.

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

roche products pty ltd - tocilizumab, quantity: 200 mg - injection, concentrated - excipient ingredients: monobasic sodium phosphate dihydrate; water for injections; polysorbate 80; sucrose; dibasic sodium phosphate dodecahydrate - rheumatoid arthritis (iv and sc formulations),actemra is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients in combination with methotrexate (mtx) or other non-biological disease-modifying anti-rheumatic drugs (dmards) in case of either an inadequate response or intolerance to previous therapy with one or more dmards. actemra is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors (see section 5.1 pharmacodynamic properties, clinical trials) in combination with mtx in those not previously treated with mtx. in the two groups of patients above, actemra can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate.,actemra has been shown to inhibit the progression of joint damage in adults, as measured by x-ray, when given in combination with methotrexate. polyarticular juvenile idiopathic arthritis (iv and sc formulations), actemra is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to or intolerance to methotrexate (mtx). actemra can be given alone or in combination with mtx.,systemic juvenile idiopathic arthritis (iv and sc formulations),intravenous formulation,actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. subcutaneous formulation actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 1 year of age and older. actemra iv and sc can be given alone or in combination with methotrexate (mtx).,cytokine release syndrome (crs) (iv formulation only), actemra is indicated for the treatment of chimeric antigen receptor (car) t cell-induced severe or life-threatening cytokine release syndrome (crs) in adults and paediatric patients 2 years of age and older. coronavirus disease 2019 (covid-19) (iv formulation only),actemra has provisional approval for the treatment of coronavirus disease 2019 (covid-19) in hospitalised adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. provisional approval has been made on the basis of short-term efficacy and safety data. continued approval depends on the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.

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

roche products pty ltd - tocilizumab, quantity: 80 mg - injection, concentrated - excipient ingredients: polysorbate 80; sucrose; monobasic sodium phosphate dihydrate; dibasic sodium phosphate dodecahydrate; water for injections - rheumatoid arthritis (iv and sc formulations), actemra is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients in combination with methotrexate (mtx) or other non-biological disease-modifying anti-rheumatic drugs (dmards) in case of either an inadequate response or intolerance to previous therapy with one or more dmards. actemra is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors (see section 5.1 pharmacodynamic properties, clinical trials) in combination with mtx in those not previously treated with mtx. in the two groups of patients above, actemra can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. actemra has been shown to inhibit the progression of joint damage in adults, as measured by x-ray, when given in combination with methotrexate.,polyarticular juvenile idiopathic arthritis (iv and sc formulations), actemra is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to or intolerance to methotrexate (mtx). actemra can be given alone or in combination with mtx.,systemic juvenile idiopathic arthritis (iv and sc formulations), intravenous formulation, actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. subcutaneous formulation actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 1 year of age and older. actemra iv and sc can be given alone or in combination with methotrexate (mtx).,cytokine release syndrome (crs) (iv formulation only), actemra is indicated for the treatment of chimeric antigen receptor (car) t cell-induced severe or life-threatening cytokine release syndrome (crs) in adults and paediatric patients 2 years of age and older. coronavirus disease 2019 (covid-19) (iv formulation only),actemra has provisional approval for the treatment of coronavirus disease 2019 (covid-19) in hospitalised adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. provisional approval has been made on the basis of short-term efficacy and safety data. continued approval depends on the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.