Європейський Союз - англійська - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - adalimumab - arthritis, rheumatoid; arthritis, juvenile rheumatoid; psoriasis; arthritis, psoriatic; spondylitis, ankylosing; uveitis; colitis, ulcerative; crohn disease - immunosuppressants - rheumatoid arthritiskromeya 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.kromeya 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 arthritiskromeya 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). idacio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). adalimumab has not been studied in patients aged less than 2 years.enthesitis-related arthritiskromeya 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 (see section 5.1).axial spondyloarthritisankylosing spondylitis (as)kromeya 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 askromeya is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated crp and/or mri, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs.psoriatic arthritiskromeya 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 (see section 5.1) and to improve physical function.psoriasiskromeya is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.paediatric plaque psoriasiskromeya 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.crohn’s diseasekromeya is indicated for treatment of moderately to severely active crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.paediatric crohn's diseasekromeya 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 a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.ulcerative colitiskromeya 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.uveitiskromeya 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.paediatric uveitiskromeya is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in 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.

Європейський Союз - англійська - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - adalimumab - arthritis, rheumatoid; arthritis, psoriatic; psoriasis; spondylitis, ankylosing; uveitis; hidradenitis suppurativa; colitis, ulcerative; crohn disease; arthritis, juvenile rheumatoid - immunosuppressants - rheumatoid arthritisidacio 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.juvenile idiopathic arthritispolyarticular juvenile idiopathic arthritisidacio 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). idacio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). adalimumab has not been studied in patients aged less than 2 years.enthesitis-related arthritisidacio 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 (see section 5.1).axial spondyloarthritisankylosing 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 asidacio is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated crp and/or mri, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs.psoriatic arthritisidacio 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 (see section 5.1) and to improve physical function.psoriasisidacio is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.paediatric plaque psoriasisidacio 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)idacio 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 diseaseidacio is indicated for treatment of moderately to severely active crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.paediatric crohn's diseaseidacio 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 a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.ulcerative colitisidacio 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.uveitisidacio 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.paediatric uveitisidacio is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in 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.

Європейський Союз - англійська - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - ozanimod hydrochloride - multiple sclerosis, relapsing-remitting; colitis, ulcerative - immunosuppressants - multiple sclerosiszeposia is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (rrms) with active disease as defined by clinical or imaging features.ulcerative colitiszeposia is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (uc) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.

Європейський Союз - англійська - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - adalimumab - arthritis, rheumatoid; arthritis, psoriatic; psoriasis; spondylitis, ankylosing; uveitis; hidradenitis suppurativa; colitis, ulcerative; crohn disease; arthritis, juvenile rheumatoid - immunosuppressants - rheumatoid arthritisyuflyma 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.yuflyma 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 arthritisyuflyma 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). yuflyma can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). adalimumab has not been studied in patients aged less than 2 years.enthesitis-related arthritisyuflyma 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 (see section 5.1).axial spondyloarthritisankylosing spondylitis (as)yuflyma 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 asyuflyma is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated crp and/or mri, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (nsaids).psoriatic arthritisyuflyma 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 (see section 5.1) and to improve physical function.psoriasisyuflyma is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.paediatric plaque psoriasisyuflyma 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)yuflyma 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 (see sections 5.1 and 5.2).crohn’s diseaseyuflyma is indicated for treatment of moderately to severely active crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.paediatric crohn's diseaseyuflyma 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 a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.ulcerative colitisyuflyma 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 colitisyuflyma 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.uveitisyuflyma 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.paediatric uveitisyuflyma is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in 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.

Європейський Союз - англійська - EMA (European Medicines Agency)

stada arzneimittel ag - adalimumab - arthritis, psoriatic; arthritis, juvenile rheumatoid; arthritis, rheumatoid; colitis, ulcerative; crohn disease; hidradenitis suppurativa; psoriasis; spondylitis, ankylosing; uveitis - immunosuppressants - rheumatoid arthritishukyndra 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 (dmards) including methotrexate has been inadequate.- the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.hukyndra 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 arthritishukyndra 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 dmard. hukyndra can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). adalimumab has not been studied in patients aged less than 2 years.enthesitis-related arthritishukyndra 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 (see section 5.1).axial spondyloarthritisankylosing spondylitis (as)hukyndra is indicated for the treatment of adults with severe active as who have had an inadequate response to conventional therapy.axial spondyloarthritis without radiographic evidence of ashukyndra is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated crp and/or mri, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (nsaids).psoriatic arthritishukyndra is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous dmard 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 (see section 5.1) and to improve physical function.psoriasishukyndra is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.paediatric plaque psoriasishukyndra 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)hukyndra is indicated for the treatment of active moderate to severe hs (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy (see sections 5.1 and 5.2).crohn’s diseasehukyndra is indicated for treatment of moderately to severely active crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.paediatric crohn's diseasehukyndra 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 a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.ulcerative colitishukyndra 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 colitishukyndra 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.uveitishukyndra 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.paediatric uveitishukyndra is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in 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.

Європейський Союз - англійська - EMA (European Medicines Agency)

stada arzneimittel ag - adalimumab - arthritis, rheumatoid; arthritis, juvenile rheumatoid; spondylitis, ankylosing; arthritis, psoriatic; psoriasis; hidradenitis suppurativa; crohn disease; colitis, ulcerative; uveitis - immunosuppressants - rheumatoid arthritislibmyris 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 (dmards) including methotrexate has been inadequate.- the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.libmyris 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 arthritislibmyris 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 dmard. libmyris can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). adalimumab has not been studied in patients aged less than 2 years.enthesitis-related arthritislibmyris 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 spondyloarthritisankylosing spondylitis (as)libmyris is indicated for the treatment of adults with severe active as who have had an inadequate response to conventional therapy.axial spondyloarthritis without radiographic evidence of aslibmyris is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated crp and/or mri, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (nsaids).psoriatic arthritislibmyris is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous dmard 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.psoriasislibmyris is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.paediatric plaque psoriasislibmyris 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)libmyris is indicated for the treatment of active moderate to severe hs (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy (see sections 5.1 and 5.2).crohn’s diseaselibmyris is indicated for treatment of moderately to severely active crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.paediatric crohn's diseaselibmyris 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 a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.ulcerative colitislibmyris 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 colitislibmyris 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.uveitislibmyris 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.paediatric uveitislibmyris is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in 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. 

Європейський Союз - англійська - EMA (European Medicines Agency)

eli lilly nederland b.v. - mirikizumab - colitis, ulcerative - immunosuppressants - omvoh is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - sulfasalazine, quantity: 500 mg - tablet, uncoated - excipient ingredients: magnesium stearate; colloidal anhydrous silica; povidone; maize starch - ulcerative colitis and crohn's disease: adjunct in the treatment of ulcerative colitis with the usual supportive and dietary measures. for the management of severe, acute attacks of ulcerative colitis, rectal and systemic corticosteroid therapy appears to be clinically superior to sulfasalazine, but sulfasalazine may be more effective than corticosteroids in reducing the number of relapses in patients on maintenance therapy. in the treatment of active crohn's disease, especially in patients with colonic involvement. rheumatoid arthritis: salazopyrin en-tabs are indicated for rheumatoid arthritis which has failed to respond to non-steroidal anti-inflammatory drugs (nsaids).

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - sulfasalazine, quantity: 500 mg - tablet, enteric coated - excipient ingredients: white beeswax; macrogol 20000; carnauba wax; magnesium stearate; povidone; cellacefate; maize starch; propylene glycol; colloidal anhydrous silica; glyceryl monostearate; purified talc - ulcerative colitis and crohn's disease: adjunct in the treatment of ulcerative colitis with the usual supportive and dietary measures. for the management of severe, acute attacks of ulcerative colitis, rectal and systemic corticosteroid therapy appears to be clinically superior to sulfasalazine, but sulfasalazine may be more effective than corticosteroids in reducing the number of relapses in patients on maintenance therapy. in the treatment of active crohn's disease, especially in patients with colonic involvement. rheumatoid arthritis: salazopyrin en-tabs are indicated for rheumatoid arthritis which has failed to respond to non-steroidal anti-inflammatory drugs (nsaids).

Ізраїль - англійська - Ministry of Health

ferring pharmaceuticals ltd - mesalazine - suppositories - mesalazine 1000 mg - mesalazine - mesalazine - ulcerative proctitis.