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

celltrion healthcare australia pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: acetic acid; polysorbate 80; sodium acetate trihydrate; glycine; water for injections - rheumatoid arthritis,yuflyma is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. yuflyma can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis,polyarticular juvenile idiopathic arthritis,yuflyma in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). yuflyma can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis,yuflyma is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis,yuflyma is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis,yuflyma is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis. crohn?s disease in adults and children (6 years and older),yuflyma is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients;,? who have had an inadequate response to conventional therapies or,,? who have lost response to or are intolerant to infliximab,ulcerative colitis,yuflyma is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time. (see 5.1 pharmacodynamic properties - clinical trials).,psoriasis in adults and children,yuflyma is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,yuflyma is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age),yuflyma is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis,yuflyma is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

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

celltrion healthcare australia pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: acetic acid; sodium acetate trihydrate; glycine; polysorbate 80; water for injections - rheumatoid arthritis,yuflyma is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. yuflyma can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis,polyarticular juvenile idiopathic arthritis,yuflyma in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). yuflyma can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis,yuflyma is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis,yuflyma is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis,yuflyma is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis. crohn?s disease in adults and children (6 years and older),yuflyma is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients;,? who have had an inadequate response to conventional therapies or,,? who have lost response to or are intolerant to infliximab,ulcerative colitis,yuflyma is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time. (see 5.1 pharmacodynamic properties - clinical trials).,psoriasis in adults and children,yuflyma is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,yuflyma is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age),yuflyma is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis,yuflyma is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

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

takeda pharmaceuticals australia pty ltd - lanadelumab, quantity: 300 mg - injection, solution - excipient ingredients: citric acid monohydrate; water for injections; dibasic sodium phosphate dihydrate; polysorbate 80; histidine; sodium chloride - takhzyro is indicated for routine prevention of recurrent attacks of hereditary angioedema (c1-esterase-inhibitor deficiency or dysfunction) in patients aged 12 years and older.

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

cipla australia pty ltd - icatibant acetate, quantity: 31.38 mg (equivalent: icatibant, qty 30 mg) - injection, solution - excipient ingredients: sodium chloride; glacial acetic acid; sodium hydroxide; water for injections - cipla icatibant is indicated for symptomatic treatment of acute attacks of hereditary angioedema (hae) in adults, adolescents and children aged 2 years and older with c1-esterase-inhibitor deficiency.

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

aspen pharmacare australia pty ltd - atropine sulfate monohydrate, quantity: 0.1027 mg/ml (equivalent: atropine sulfate, qty 0.1 mg/ml) - eye drops, solution - excipient ingredients: citric acid monohydrate; sodium chloride; hydrochloric acid; water for injections; sodium hydroxide - eikance 0.01% is indicated as a treatment to slow the progression of myopia in children aged from 4 to 14 years. atropine treatment may be initiated in children when myopia progresses greater than or equal to -1.0 d per year.

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

theramex australia pty ltd - ganirelix, quantity: 0.25 mg - injection, solution - excipient ingredients: glacial acetic acid; water for injections; mannitol; sodium hydroxide - for the prevention of premature luteinisation and ovulation in patients undergoing controlled ovarian stimulation, followed by oocyte pick up and assisted reproductive techniques

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

alphapharm pty ltd - amitriptyline hydrochloride, quantity: 50 mg - tablet, film coated - excipient ingredients: sodium starch glycollate; pregelatinised maize starch; colloidal anhydrous silica; lactose monohydrate; magnesium stearate; purified talc; disodium edetate; microcrystalline cellulose; titanium dioxide; hypromellose; iron oxide yellow; iron oxide red; macrogol 4000; iron oxide black - amitriptyline alphapharm 50mg tablets are indicated only for the maintenance treatment of major depression. (see precautions). nocturnal enuresis where organic pathology has been excluded.

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

amdipharm mercury australia pty ltd - nortriptyline hydrochloride, quantity: 11.4 mg (equivalent: nortriptyline, qty 10 mg) - tablet, uncoated - excipient ingredients: lactose monohydrate; magnesium stearate; maize starch - treatment of major depression

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

amdipharm mercury australia pty ltd - nortriptyline hydrochloride, quantity: 28.5 mg (equivalent: nortriptyline, qty 25 mg) - tablet, uncoated - excipient ingredients: maize starch; lactose monohydrate; magnesium stearate - treatment of major depression

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

fresenius kabi australia pty ltd - paracetamol, quantity: 10 mg/ml - injection, solution - excipient ingredients: cysteine hydrochloride monohydrate; mannitol; water for injections; nitrogen - paracetamol 10 mg/ml, solution for infusion is indicated for the relief of mild to moderate pain and the reduction of fever where an intravenous route of administration is considered clinically necessary.