Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - ustekinumab, quantity: 90 mg - injection, solution - excipient ingredients: histidine hydrochloride monohydrate; sucrose; water for injections; polysorbate 80; histidine - plaque psoriasis,adults - stelara is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.,paediatric population, 6 years and older - stelara is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from 6 years of age who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.,psoriatic arthritis (psa),stelara, alone or in combination with methotrexate, is indicated for the treatment of signs and symptoms of active psoriatic arthritis in adult patients (18 years and older) where response to previous non-biological dmard therapy has been inadequate.,crohn?s disease,stelara 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 tnf alpha antagonist or have medical contraindications to such therapies.,ulcerative colitis,stelara is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - ustekinumab, quantity: 45 mg - injection, solution - excipient ingredients: water for injections; sucrose; polysorbate 80; histidine; histidine hydrochloride monohydrate - plaque psoriasis,adults - stelara is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.,paediatric population, 6 years and older - stelara is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from 6 years of age who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.,psoriatic arthritis (psa),stelara, alone or in combination with methotrexate, is indicated for the treatment of signs and symptoms of active psoriatic arthritis in adult patients (18 years and older) where response to previous non-biological dmard therapy has been inadequate.,crohn?s disease,stelara 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 tnf alpha antagonist or have medical contraindications to such therapies.,ulcerative colitis,stelara is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - ustekinumab, quantity: 45 mg - injection, solution - excipient ingredients: histidine; polysorbate 80; histidine hydrochloride monohydrate; water for injections; sucrose - plaque psoriasis,adults - stelara is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.,paediatric population, 6 years and older - stelara is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from 6 years of age who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.,psoriatic arthritis (psa),stelara, alone or in combination with methotrexate, is indicated for the treatment of signs and symptoms of active psoriatic arthritis in adult patients (18 years and older) where response to previous non-biological dmard therapy has been inadequate.,crohn?s disease,stelara 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 tnf alpha antagonist or have medical contraindications to such therapies.,ulcerative colitis,stelara is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.

Нови Зеланд - Енглески - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - golimumab 50mg;   - solution for injection - 50 mg - active: golimumab 50mg   excipient: histidine polysorbate 80 sorbitol water for injection - rheumatoid arthritis: simponi, in combination with mtx, is indicated for: · the treatment of active rheumatoid arthritis in adult patients when the response to dmard therapy has been inadequate. · the treatment of active rheumatoid arthritis in adult patients not previously treated with mtx. simponi has also been shown to reduce the rate of progression of joint damage as measured by x-ray, improve physical function and health related quality of life. simponi can be used in patients previously treated with one or more tnf inhibitor(s).

Нови Зеланд - Енглески - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - golimumab 50mg;   - solution for injection - 50 mg - active: golimumab 50mg   excipient: histidine polysorbate 80 sorbitol water for injection - rheumatoid arthritis: simponi, in combination with mtx, is indicated for: · the treatment of active rheumatoid arthritis in adult patients when the response to dmard therapy has been inadequate. · the treatment of active rheumatoid arthritis in adult patients not previously treated with mtx. simponi has also been shown to reduce the rate of progression of joint damage as measured by x-ray, improve physical function and health related quality of life. simponi can be used in patients previously treated with one or more tnf inhibitor(s).

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

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

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - hydrochlorothiazide, quantity: 12.5 mg; irbesartan, quantity: 150 mg - tablet - excipient ingredients: croscarmellose sodium; colloidal anhydrous silica; povidone; microcrystalline cellulose; magnesium stearate; hydrogenated castor oil; maize starch; lactose monohydrate - stada irbesartan hct is indicated for the treatment of hypertension. treatment should not be initiated with this fixed dose combination.

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - hydrochlorothiazide, quantity: 12.5 mg; irbesartan, quantity: 300 mg - tablet - excipient ingredients: colloidal anhydrous silica; microcrystalline cellulose; povidone; hydrogenated castor oil; maize starch; magnesium stearate; lactose monohydrate; croscarmellose sodium - stada irbesartan hct is indicated for the treatment of hypertension. treatment should not be initiated with this fixed dose combination.

Израел - Енглески - Ministry of Health

abbvie biopharmaceuticals ltd, israel - adalimumab - solution for injection - adalimumab 100 mg / 1 ml - adalimumab - • rheumatoid arthritis:humira 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.humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.humira 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.• polyarticular juvenile idiopathic arthritis:humira 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). humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. humira has not been studied in patients aged less than 2 years.• enthesitis-related arthritis:humira 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 therapy.• axial spondyloarthritis :humira 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:humira 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:humira 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. humira 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:humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.• paediatric plaque psoriasis:humira 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):humira is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy.• crohn’s disease:humira 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. humira 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:humira 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:humira 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:humira 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:humira is indicated for the treatment of intestinal behcet’s disease in patients who have had an inadequate response to conventional therapy.• paediatric uveitishumira 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.• paediatric ulcerative colitis humira is indicated for the treatment of moderately to severely active ulcerative colitis in pediatric 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

Израел - Енглески - Ministry of Health

abbvie biopharmaceuticals ltd, israel - upadacitinib as hemihydrate - tablets prolonged release - upadacitinib as hemihydrate 45 mg - upadacitinib - ulcerative colitisrinvoq 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 biologic agent.crohn’s diseaserinvoq 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 biologic agent.