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

biomarin pharmaceutical australia pty ltd - vosoritide, quantity: 0.56 mg - injection, powder for - excipient ingredients: mannitol; sodium citrate dihydrate; citric acid monohydrate; polysorbate 80; trehalose dihydrate; methionine - voxzogo is indicated for the treatment of achondroplasia in paediatric patients whose epiphyses are not closed. the diagnosis of achondroplasia should be confirmed by appropriate genetic testing.

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

biomarin pharmaceutical australia pty ltd - vosoritide, quantity: 0.4 mg - injection, powder for - excipient ingredients: citric acid monohydrate; mannitol; polysorbate 80; methionine; trehalose dihydrate; sodium citrate dihydrate - voxzogo is indicated for the treatment of achondroplasia in paediatric patients whose epiphyses are not closed. the diagnosis of achondroplasia should be confirmed by appropriate genetic testing.

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

novartis pharmaceuticals australia pty ltd - voretigene neparvovec, quantity: 1 dna - injection, concentrated - excipient ingredients: monobasic sodium phosphate; dibasic sodium phosphate; sodium chloride; poloxalene - luxturna is indicated for the treatment of patients with inherited retinal dystrophy caused by pathological biallelic rpe65 mutations and who have sufficient viable retinal cells as determined by the treating physician.,pathological mutations of rpe65 should be confirmed by a national association of testing authorities (nata) or international laboratory accreditation cooperation (ilac) accredited laboratory.

Australia - English - 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 - English - 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 - English - 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 - English - 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 - English - 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 - English - 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 - English - 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.