אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

amneal pharma australia pty ltd - hydrochlorothiazide,irbesartan -

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

amneal pharma australia pty ltd - hydrochlorothiazide,irbesartan -

ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

amgen new zealand limited - adalimumab 50 mg/ml;   - solution for injection - 20 mg/0.4ml - active: adalimumab 50 mg/ml   excipient: glacial acetic acid polysorbate 80 sodium hydroxide sucrose water for injection - rheumatoid arthritis amgevita 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. amgevita can be used alone or in combination with methotrexate.

ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

amgen new zealand limited - adalimumab 50 mg/ml;   - solution for injection - 40 mg/0.8ml - active: adalimumab 50 mg/ml   excipient: glacial acetic acid polysorbate 80 sodium hydroxide sucrose water for injection - rheumatoid arthritis amgevita 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. amgevita can be used alone or in combination with methotrexate.

ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

amgen new zealand limited - adalimumab 50 mg/ml;   - solution for injection - 40 mg/0.8ml - active: adalimumab 50 mg/ml   excipient: glacial acetic acid polysorbate 80 sodium hydroxide sucrose water for injection - rheumatoid arthritis amgevita 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. amgevita can be used alone or in combination with methotrexate.

ישראל - אנגלית - Ministry of Health

novartis israel ltd - adalimumab - solution for injection - adalimumab 50 mg/ml - adalimumab - rheumatoid arthritis hyrimoz in combination with methotrexate is indicated for:  the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. hyrimoz can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.adalimumab has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function, when given in combination with methotrexate. juvenile idiopathic arthritispolyarticular juvenile idiopathic arthritis:hyrimoz in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (dmards). hyrimoz can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate . adalimumab has not been studied in patients aged less than 2 years. enthesitis-related arthritis:hyrimoz is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapyaxial spondyloarthritisankylosing spondylitis (as): hyrimoz is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. axial spondyloarthritis without radiographic evidence of as: hyrimoz is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as, but with objective signs of inflammation by radiological and/or laboratory tests including mri and serum crp levels , who have had an inadequate response to, or are intolerant to, non - steroidal anti-inflammatory drugs. psoriatic arthritis hyrimoz is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function. psoriasis hyrimoz is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasis hyrimoz is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.hidradenitis suppurativa (hs)hyrimoz is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy. crohn’s disease hyrimoz is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active crohn’s disease who have had an inadequate response to conventional therapy. hyrimoz is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.paediatric crohn's disease hyrimoz is indicated for the treatment of moderately to severely active crohn's disease in paediatric patients (from 6- years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and corticosteroid, and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies ulcerative colitis hyrimoz is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6- mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies.paediatric ulcerative colitis hyrimoz is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies.uveitis hyrimoz is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroidsparing, or in whom corticosteroid treatment is inappropriate.paediatric uveitis hyrimoz is indicated for the treatment of chronic non-infectious uveitis in paediatric patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.intestinal behcet’s diseasehyrimoz is indicated for the treatment of intestinal behcet’s disease in patients who have had an inadequate response to conventional therapy.

ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - infliximab 100mg;   - powder for injection - 100 mg - active: infliximab 100mg   excipient: dibasic sodium phosphate dihydrate monobasic sodium phosphate monohydrate polysorbate 80 sucrose - rheumatoid arthritis remicade is a ?disease-controlling anti-rheumatic therapy" (dcart) indicated for: · the reduction of signs and symptoms · prevention of structural joint damage (erosions and joint space narrowing) · improvement in physical function in patients with active disease. remicade should be given in combination with methotrexate.

ישראל - אנגלית - Ministry of Health

neopharm (israel)1996 ltd - adalimumab - solution for injection - adalimumab 50 mg/ml - adalimumab - • rheumatoid arthritis: idacio in combination with methotrexate is indicated for:- the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.- the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. idacio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. adalimumab has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function, when given in combination with methotrexate.• axial spondyloarthritis:-ankylosing spondylitis (as): idacio is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.-axial spondyloarthritis without radiographic evidence of as: idacio is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as, but with objective signs of inflammation by radiological and/or laboratory tests including mri and serum crp levels, who have had an inadequate response to, or are intolerant to, non-steroidal anti-inflammatory drugs.• psoriatic arthritis: idacio is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti rheumatic drug therapy has been inadequate. adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function.• psoriasis: idacio is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.• hidradenitis suppurativa (hs): idacio is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic hs therapy.• crohn’s disease: idacio is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active crohn’s disease who have had an inadequate response to conventional therapy. idacio is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab. • ulcerative colitis: idacio is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. • uveitis:idacio is indicated for the treatment of non-infectious intermediate, posterior and panuveitis 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.• intestinal behcet's disease: idacio is indicated for the treatment of intestinal behcet’s disease in patients who have had an inadequate response to conventional therapy.

ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

abbvie limited - upadacitinib hemihydrate 15.4mg equivalent to upadacitinib 15mg - modified release tablet - 15 mg - active: upadacitinib hemihydrate 15.4mg equivalent to upadacitinib 15mg excipient: colloidal silicon dioxide hypromellose magnesium stearate mannitol microcrystalline cellulose opadry purple 85f100091 tartaric acid - rinvoq is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis. rinvoq may be used as monotherapy or in combination with methotrexate or other conventional synthetic disease modifying anti-rheumatic drugs (csdmards).

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - hydrochlorothiazide, quantity: 25 mg; irbesartan, quantity: 300 mg - tablet - excipient ingredients: magnesium stearate; lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; povidone; hydrogenated castor oil; colloidal anhydrous silica; maize starch - irbesartan hct medis is indicated for the treatment of hypertension. treatment should not be initiated with this fixed dose combination.