Europäische Union - Deutsch - 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 - immunsuppressiva - 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 wurde gezeigt, zur verringerung der rate des fortschreitens von gelenkschäden, wie gemessen, durch die x-ray und für die verbesserung der physischen funktion, wenn sie in kombination mit methotrexat. 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. adalimumab wurde nicht untersucht bei patienten im alter von weniger als 2 jahren. 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 wurde gezeigt, zur verringerung der rate des fortschreitens peripherer gelenkschäden, wie gemessen, durch die x-ray bei patienten mit polyarticular symmetrischen subtypen der erkrankung und verbessert die physische funktion. 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 und 5. 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.

Schweiz - Deutsch - Swissmedic (Swiss Agency for Therapeutic Products)

spirig healthcare ag - adalimumabum - injektionslösung in einer fertigspritze - lösung: adalimumabum 40 mg, natrii chloridum corresp. natrium 0.09 mg, saccharum, polysorbatum 80, aqua ad iniectabile q.s. ad solutionem pro 0.4 ml. - rheumatoide arthritis, früh diagnostizierte rheumatoide arthritis, psoriasis-arthritis, ankylosierende spondylitis (morbus bechterew) morbus crohn, plaque-psoriasis, colitis ulcerosa, polyartikuläre juvenile idiopathische arthritis, hidradenitis suppurativa, uveitis - biotechnologika

Schweiz - Deutsch - Swissmedic (Swiss Agency for Therapeutic Products)

spirig healthcare ag - adalimumabum - injektionslösung in einer fertigspritze - lösung: adalimumabum 80 mg, natrii chloridum corresp. natrium 0.181 mg, saccharum, polysorbatum 80, aqua ad iniectabile q.s. ad solutionem pro 0.8 ml. - rheumatoide arthritis, früh diagnostizierte rheumatoide arthritis, psoriasis-arthritis, ankylosierende spondylitis (morbus bechterew) morbus crohn, plaque-psoriasis, colitis ulcerosa, polyartikuläre juvenile idiopathische arthritis, hidradenitis suppurativa, uveitis - biotechnologika

Schweiz - Deutsch - Swissmedic (Swiss Agency for Therapeutic Products)

spirig healthcare ag - adalimumabum - injektionslösung im fertigpen - lösung: adalimumabum 40 mg, natrii chloridum corresp. natrium 0.09 mg, saccharum, polysorbatum 80, aqua ad iniectabile q.s. ad solutionem pro 0.4 ml. - rheumatoide arthritis, früh diagnostizierte rheumatoide arthritis, psoriasis-arthritis, ankylosierende spondylitis (morbus bechterew) morbus crohn, plaque-psoriasis, colitis ulcerosa, polyartikuläre juvenile idiopathische arthritis, hidradenitis suppurativa, uveitis - biotechnologika

Schweiz - Deutsch - Swissmedic (Swiss Agency for Therapeutic Products)

iqone healthcare switzerland sa - adalimumabum - solution injectable en seringue préremplie avec protège-aiguille - adalimumabum 40 mg, acidum aceticum, natrii acetas trihydricus corresp. natrium 0.07 mg, glycinum, polysorbatum 80, aqua ad iniectabile ad solutionem pro 0.4 ml. - polyarthrite rhumatoïde, arthrite juvénile idiopathique polyarticulaire, arthrite psoriasique, spondylarthrite ankylosante, maladie de crohn chez l'adulte, colite ulcéreuse, psoriasis chez l'adulte, l'adolescent et l'enfant, hidradénite suppurée, uvéite - biotechnologika

Schweiz - Deutsch - Swissmedic (Swiss Agency for Therapeutic Products)

iqone healthcare switzerland sa - adalimumabum - injektionslösung in einem fertigpen - adalimumabum 40 mg, acidum aceticum, natrii acetas trihydricus corresp. natrium 0.07 mg, glycinum, polysorbatum 80, aqua ad iniectabile ad solutionem pro 0.4 ml. - polyarthrite rhumatoïde, arthrite juvénile idiopathique polyarticulaire, arthrite psoriasique, spondylarthrite ankylosante, maladie de crohn chez l'adulte, colite ulcéreuse, psoriasis chez l'adulte, l'adolescent et l'enfant, hidradénite suppurée, uvéite - biotechnologika

Schweiz - Deutsch - Swissmedic (Swiss Agency for Therapeutic Products)

iqone healthcare switzerland sa - adalimumabum - solution injectable en seringue préremplie avec protège-aiguille - adalimumabum 80 mg, acidum aceticum, natrii acetas trihydricus corresp. natrium 0.14 mg, glycinum, polysorbatum 80, aqua ad iniectabile ad solutionem pro 0.8 ml. - polyarthrite rhumatoïde, arthrite juvénile idiopathique polyarticulaire, arthrite psoriasique, spondylarthrite ankylosante, maladie de crohn chez l'adulte, colite ulcéreuse, psoriasis chez l'adulte, l'adolescent et l'enfant, hidradénite suppurée, uvéite - biotechnologika

Schweiz - Deutsch - Swissmedic (Swiss Agency for Therapeutic Products)

iqone healthcare switzerland sa - adalimumabum - injektionslösung in einem fertigpen - adalimumabum 80 mg, acidum aceticum, natrii acetas trihydricus corresp. natrium 0.14 mg, glycinum, polysorbatum 80, aqua ad iniectabile ad solutionem pro 0.8 ml. - polyarthrite rhumatoïde, arthrite juvénile idiopathique polyarticulaire, arthrite psoriasique, spondylarthrite ankylosante, maladie de crohn chez l'adulte, colite ulcéreuse, psoriasis chez l'adulte, l'adolescent et l'enfant, hidradénite suppurée, uvéite - biotechnologika