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

pfizer australia pty ltd - tozinameran, quantity: 225 microgram - injection, suspension - excipient ingredients: ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate); water for injections; cholesterol; 2-((polyethylene glycol)-2000)-n-n-ditetradecylacetamide; sucrose; distearoylphosphatidylcholine; trometamol; trometamol hydrochloride - active immunisation to prevent coronavirus disease 2019 (covid-19) caused by sars-cov-2, in individuals 12 years of age and older.,the use of this vaccine should be in accordance with official recommendations.

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

pfizer australia pty ltd - tozinameran, quantity: 130 microgram - injection, concentrated - excipient ingredients: ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate); water for injections; cholesterol; 2-((polyethylene glycol)-2000)-n-n-ditetradecylacetamide; sucrose; distearoylphosphatidylcholine; trometamol; trometamol hydrochloride - active immunisation to prevent coronavirus disease 2019 (covid-19) caused by sars-cov-2, in individuals 5 years of age to less than 12 years of age.,the use of this vaccine should be in accordance with official recommendations.

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

pfizer australia pty ltd - tozinameran, quantity: 0.5 mg/ml - injection, concentrated - excipient ingredients: ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate); dibasic sodium phosphate dihydrate; water for injections; cholesterol; monobasic potassium phosphate; sodium chloride; potassium chloride; 2-((polyethylene glycol)-2000)-n-n-ditetradecylacetamide; sucrose; distearoylphosphatidylcholine - active immunisation to prevent coronavirus disease 2019 (covid-19) caused by sars-cov-2, in individuals 12 years of age and older.,the use of this vaccine should be in accordance with official recommendations.

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

pfizer australia pty ltd - tofacitinib citrate, quantity: 16.155 mg (equivalent: tofacitinib, qty 10 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; croscarmellose sodium; magnesium stearate; titanium dioxide; hypromellose; triacetin; brilliant blue fcf aluminium lake; macrogol 3350; indigo carmine aluminium lake - ulcerative colitis (uc),xeljanz is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biological therapy.

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

astrazeneca pty ltd - tixagevimab, quantity: 150 mg - injection, solution - excipient ingredients: sucrose; polysorbate 80; water for injections; histidine; histidine hydrochloride monohydrate - pre-exposure prophylaxis,evusheld (tixagevimab and cilgavimab) has provisional approval for the pre-exposure prophylaxis of covid-19 in adults and adolescents aged 12 years and older weighing at least 40 kg,,- who have moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments that make it likely that they will not mount an adequate immune response to covid-19 vaccination or,- for whom vaccination with any approved covid-19 vaccine is not recommended due to a history of severe adverse reaction (e.g., severe allergic reaction) to a covid-19 vaccine(s) and/or covid-19 vaccine component(s).,see section 4.2 dose and method of administration and section 5.2 pharmacokinetic properties.,evusheld is not recommended as a substitute for vaccination in individuals for whom covid-19 vaccination is recommended.,this decision 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 data from ongoing clinical trials.,treatment,evusheld has provisional approval for the treatment of adults with covid-19, who do not require supplemental oxygen and who are at increased risk of progressing to severe covid-19. see section 4.2 dose and method of administration and section 5.2 pharmacokinetic properties.,this decision 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 data from ongoing clinical trial.

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

sun pharma anz pty ltd - tildrakizumab, quantity: 100 mg/ml - injection, solution - excipient ingredients: histidine; sucrose; water for injections; polysorbate 80; histidine hydrochloride monohydrate - ilumya is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.

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

link medical products pty ltd t/a link pharmaceuticals - thiotepa, quantity: 400 mg - injection, solvent for - excipient ingredients: sodium chloride; water for injections - tepadina is indicated, in combination with other chemotherapy medicinal products: ? with or without total body irradiation (tbi), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (hpct) in haematological diseases in adult and paediatric patients; ? when high dose chemotherapy with hpct support is appropriate for the treatment of solid tumours in adult and paediatric patients (refer to section 5.1 pharmacodynamic properties - clinical trials).

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

link medical products pty ltd t/a link pharmaceuticals - thiotepa, quantity: 15 mg - injection, powder for - excipient ingredients: - tepadina is indicated, in combination with other chemotherapy medicinal products: ? with or without total body irradiation (tbi), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (hpct) in haematological diseases in adult and paediatric patients; ? when high dose chemotherapy with hpct support is appropriate for the treatment of solid tumours in adult and paediatric patients (refer to section 5.1 pharmacodynamic properties - clinical trials).

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

link medical products pty ltd t/a link pharmaceuticals - thiotepa, quantity: 100 mg - injection, powder for - excipient ingredients: - tepadina is indicated, in combination with other chemotherapy medicinal products: ? with or without total body irradiation (tbi), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (hpct) in haematological diseases in adult and paediatric patients; ? when high dose chemotherapy with hpct support is appropriate for the treatment of solid tumours in adult and paediatric patients (refer to section 5.1 pharmacodynamic properties - clinical trials).

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

vertex pharmaceuticals australia pty ltd - tezacaftor, quantity: 50 mg; ivacaftor, quantity: 75 mg - tablet, film coated - excipient ingredients: hypromellose acetate succinate; sodium lauryl sulfate; hypromellose; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; titanium dioxide; hyprolose; purified talc - symdeko is indicated for the treatment of patients with cystic fibrosis (cf) aged 6 years and older who are homozygous for the f508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence.,refer to table 1 for a list of responsive mutations.