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

abbvie pty ltd - upadacitinib hemihydrate, quantity: 46.1 mg (equivalent: upadacitinib, qty 45 mg) - tablet, modified release - excipient ingredients: microcrystalline cellulose; hypromellose; mannitol; tartaric acid; colloidal anhydrous silica; magnesium stearate; polyvinyl alcohol; macrogol 3350; purified talc; titanium dioxide; iron oxide red; iron oxide yellow - ulcerative colitis,rinvoq 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 medicine.,crohn?s disease,rinvoq is indicated for the treatment of adult patients with moderately to severely active crohn?s disease, who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biological medicine.

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

abbvie pty ltd - upadacitinib hemihydrate, quantity: 30.7 mg (equivalent: upadacitinib, qty 30 mg) - tablet, modified release - excipient ingredients: microcrystalline cellulose; hypromellose; mannitol; tartaric acid; colloidal anhydrous silica; magnesium stearate; polyvinyl alcohol; macrogol 3350; purified talc; titanium dioxide; iron oxide red - atopic dermatitis,rinvoq is indicated for use in adults and adolescents aged 12 years and above who weigh at least 40 kg, for the treatment of moderate to severe atopic dermatitis which is inadequately controlled with active topical pharmacotherapies and for whom systemic therapy is indicated.,ulcerative colitis,rinvoq 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 medicine. crohn?s disease,rinvoq is indicated for the treatment of adult patients with moderately to severely active crohn?s disease, who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biological medicine.

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

abbvie pty ltd - upadacitinib hemihydrate, quantity: 15.4 mg (equivalent: upadacitinib, qty 15 mg) - tablet, modified release - excipient ingredients: purified talc; tartaric acid; titanium dioxide; microcrystalline cellulose; macrogol 3350; mannitol; colloidal anhydrous silica; hypromellose; magnesium stearate; ferrosoferric oxide; iron oxide red; polyvinyl alcohol - rheumatoid arthritis,rinvoq is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying anti-rheumatic drugs (dmards).,rinvoq may be used as monotherapy or in combination with methotrexate or other conventional synthetic disease-modifying anti-rheumatic drugs (csdmards).,psoriatic arthritis,rinvoq is indicated for the treatment of moderate to severe active psoriatic arthritis in adult patients who have responded inadequately to, or are intolerant to one or more dmards.,rinvoq may be used as monotherapy or in combination with a non-biological dmard.,non-radiographic axial spondyloarthritis,rinvoq is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) change, who have responded inadequately to, or are intolerant to nonsteroidal anti-inflammatory drugs (nsaids).,ankylosing spondylitis,rinvoq is indicated for the treatment of adults with active ankylosing spondylitis.,atopic dermatitis,rinvoq is indicated for use in adults and adolescents aged 12 years and above who weigh at least 40 kg, for the treatment of moderate to severe atopic dermatitis which is inadequately controlled with active topical pharmacotherapies and for whom systemic therapy is indicated.,ulcerative colitis,rinvoq 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 medicine. crohn?s disease,rinvoq is indicated for the treatment of adult patients with moderately to severely active crohn?s disease, who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biological medicine.

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

echo therapeutics pty ltd - trimethoprim, quantity: 80 mg; sulfamethoxazole, quantity: 400 mg - injection, concentrated - excipient ingredients: ethanol absolute; water for injections; monoethanolamine; propylene glycol; sodium hydroxide - parenteral administration of bactrim is indicated where oral dosage is not desirable or practical, e.g. pre- and post-operative infections associated with surgery, trauma or gynaecology; septicaemia and other infections due to sensitive organisms such as typhoid and paratyphoid.

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

galderma australia pty ltd - trifarotene, quantity: 50 microgram/g - cream - excipient ingredients: purified water; propylene glycol; allantoin; medium chain triglycerides; phenoxyethanol; cyclomethicone; ethanol; polysorbate 80; acrylamide/sodium acryloyldimethyltaurate copolymer; isohexadecane; sorbitan oleate - aklief is indicated for the topical treatment of acne vulgaris of the face and/or the trunk in patients from 12 years of age and older, when many comedones, papules and/or pustules are present.

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

galderma australia pty ltd - trifarotene, quantity: 50 microgram/g - cream - excipient ingredients: purified water; propylene glycol; allantoin; medium chain triglycerides; phenoxyethanol; cyclomethicone; ethanol; polysorbate 80; acrylamide/sodium acryloyldimethyltaurate copolymer; isohexadecane; sorbitan oleate - aklief is indicated for the topical treatment of acne vulgaris of the face and/or the trunk in patients from 12 years of age and older, when many comedones, papules and/or pustules are present.

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

waymade australia pty limited - trientine dihydrochloride, quantity: 250 mg - capsule - excipient ingredients: gelatin; stearic acid; titanium dioxide; purified water; sunset yellow fcf; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - trientine waymade is indicated in the treatment of patients with wilson?s disease who are intolerant of penicillamine.

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

link medical products pty ltd t/a link pharmaceuticals - treosulfan, quantity: 5 g - solution, powder for - excipient ingredients: - adults with acute myeloid leukaemia (aml) or myelodysplastic syndrome (mds) trecondi (treosulfan) is indicated in combination with fludarabine as part of conditioning treatment prior to allogeneic hematopoietic stem cell transplantation (allohsct) in adult patients with aml or mds at increased risk for standard conditioning therapies.,paediatric patients aged 1 month and older with malignant and non-malignant haematological diseases trecondi (treosulfan) is indicated in combination with fludarabine, with or without thiotepa, as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (allohsct) in paediatric patients older than one month with malignant and non-malignant diseases.

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

link medical products pty ltd t/a link pharmaceuticals - treosulfan, quantity: 1 g - solution, powder for - excipient ingredients: - adults with acute myeloid leukaemia (aml) or myelodysplastic syndrome (mds) trecondi (treosulfan) is indicated in combination with fludarabine as part of conditioning treatment prior to allogeneic hematopoietic stem cell transplantation (allohsct) in adult patients with aml or mds at increased risk for standard conditioning therapies.,paediatric patients aged 1 month and older with malignant and non-malignant haematological diseases trecondi (treosulfan) is indicated in combination with fludarabine, with or without thiotepa, as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (allohsct) in paediatric patients older than one month with malignant and non-malignant diseases.

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

astrazeneca pty ltd - trastuzumab deruxtecan, quantity: 100 mg - injection, powder for - excipient ingredients: sucrose; histidine hydrochloride monohydrate; histidine; polysorbate 80 - metastatic breast cancer,her2-positive,enhertu as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic her2-positive breast cancer who previously received:,trastuzumab and a taxane for metastatic disease, or,one prior anti-her2-based regimen and developed disease recurrence during or within six months of completing neo-adjuvant or adjuvant therapy.,her2-low,enhertu is indicated for the treatment of adult patients with unresectable or metastatic her2-low (ihc 1+ or ihc 2+/ish-negative) breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.,patients with hormone receptor positive (hr+) breast cancer should additionally have received and no longer be considered eligible for endocrine therapy.