Սլովակիա - սլովակերեն - ŠÚKL (Štátny ústav pre kontrolu liečiv)

easymed s.r.o., Česká republika - metotrexát - 29 - antirheumatica, antiphlogistica, antiuratica

Սլովակիա - սլովակերեն - ŠÚKL (Štátny ústav pre kontrolu liečiv)

easymed s.r.o., Česká republika - metotrexát - 29 - antirheumatica, antiphlogistica, antiuratica

Սլովակիա - սլովակերեն - ŠÚKL (Štátny ústav pre kontrolu liečiv)

teva pharmaceuticals slovakia s.r.o., slovensko - metotrexát - 44 - cytostatica

Սլովակիա - սլովակերեն - ŠÚKL (Štátny ústav pre kontrolu liečiv)

teva pharmaceuticals slovakia s.r.o., slovensko - metotrexát - 44 - cytostatica

Եվրոպական Միություն - սլովակերեն - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - adalimumab - hidradenitis suppurativa; arthritis, psoriatic; psoriasis; crohn disease; arthritis, juvenile rheumatoid; uveitis; arthritis, rheumatoid; colitis, ulcerative; spondylitis, ankylosing - imunosupresíva - pozrite si časť 4. 1 v súhrne charakteristických vlastností výrobku v informačnom dokumente o výrobku.

Եվրոպական Միություն - սլովակերեն - EMA (European Medicines Agency)

amgen europe b.v. - adalimumab - arthritis, psoriatic; spondylitis, ankylosing; crohn disease; colitis, ulcerative; hidradenitis suppurativa; psoriasis; arthritis, rheumatoid - imunosupresíva - pozrite si časť 4. 1 v súhrne charakteristických vlastností výrobku v informačnom dokumente o výrobku.

Եվրոպական Միություն - սլովակերեն - EMA (European Medicines Agency)

janssen biologics b.v. - golimumab - arthritis, psoriatic; spondylitis, ankylosing; colitis, ulcerative; arthritis, rheumatoid - imunosupresíva - reumatoidná artritída (ra)simponi, v kombinácii s metotrexátom (mtx), je indikovaný na:liečbu stredne ťažkej, aktívnej reumatoidnej artritídy u dospelých, keď odpoveď na ochorenie modifikujúce anti reumatických drog (dmard) terapia vrátane mtx bola neprimeraná. na liečbu ťažkej, aktívnej a progresívnej reumatoidnej artritídy u dospelých, ktoré predtým neboli liečení mtx. simponi, v kombinácii s mtx, bolo preukázané, že znižujú rýchlosť progresie poškodenia kĺbov merané x ray a zlepšiť telesné funkcie. pre informácie týkajúce sa polyartikulárnou juvenilnou idiopatickou artritídou označenie, prečítajte si simponi 50 mg smpc. psoriatická artritída (psa)simponi, samostatne alebo v kombinácii s mtx, je indikovaná na liečbu aktívnej a progresívnej psoriatická artritída u dospelých pacientov, ak odpoveď na predchádzajúcu dmard terapia bola neprimeraná. simponi bolo preukázané, že znižujú rýchlosť progresie periférne poškodenie kĺbov, merané x ray u pacientov s polyartikulárnou symetrické subtypes ochorenia (pozri časť 5. 1) a na zlepšenie fyzickej funkcie. axiálne spondyloarthritisankylosing spondylitída (as)simponi je indikovaný na liečbu ťažkej, aktívnej ankylozujúcej spondylitíde u dospelých, ktorí reagovali neadekvátne konvenčná terapia. non radiographic axiálne spondyloarthritis (nr axiálne spa)simponi je indikovaný na liečbu dospelých pacientov s ťažkou, aktívne non radiographic axiálne spondyloarthritis objektívne príznaky zápalu, ako je uvedené zvýšenej c reaktívneho proteínu (crp) a/alebo magnetickou rezonanciou (mri) dôkazy, ktorí mali nedostatočnú odpoveď na, alebo netolerujú nesteroidné protizápalové lieky (nsaid). ulcerózna kolitída (uc)simponi je indikovaný na liečbu mierne až ťažkou aktívnou ulcerózna kolitída u dospelých pacientov, ktorí mali nedostatočnú odpoveď na konvenčnú liečbu vrátane kortikosteroidov a 6 mercaptopurine (6 mp) alebo azatioprin (aza), alebo ktorí netolerujú, alebo majú zdravotné kontraindikácie pre tieto terapie. juvenilná idiopatická arthritispolyarticular juvenilnej idiopatickej artritídy (pjia)simponi v kombinácii s metotrexátom (mtx) je indikovaný na liečbu polyartikulárnou juvenilnou idiopatickou artritídou vo deti od 2 rokov veku a starších, ktorí reagovali neadekvátne k predchádzajúcej terapie s mtx. reumatoidná artritída (ra)simponi, v kombinácii s metotrexátom (mtx), je indikovaný na:liečbu stredne ťažkej, aktívnej reumatoidnej artritídy u dospelých, keď odpoveď na ochorenie modifikujúce anti reumatických drog (dmard) terapia vrátane mtx bola neprimeraná. na liečbu ťažkej, aktívnej a progresívnej reumatoidnej artritídy u dospelých, ktoré predtým neboli liečení mtx. simponi, v kombinácii s mtx, bolo preukázané, že znižujú rýchlosť progresie poškodenia kĺbov merané x ray a zlepšiť telesné funkcie. juvenilná idiopatická arthritispolyarticular juvenilnej idiopatickej artritídy (pjia)simponi v kombinácii s mtx je indikovaný na liečbu polyartikulárnou juvenilnou idiopatickou artritídou vo deti od 2 rokov veku a starších, ktorí reagovali neadekvátne k predchádzajúcej terapie s mtx. psoriatická artritída (psa)simponi, samostatne alebo v kombinácii s mtx, je indikovaná na liečbu aktívnej a progresívnej psoriatická artritída u dospelých pacientov, ak odpoveď na predchádzajúcu dmard terapia bola neprimeraná. simponi bolo preukázané, že znižujú rýchlosť progresie periférne poškodenie kĺbov, merané x ray u pacientov s polyartikulárnou symetrické subtypes ochorenia (pozri časť 5. 1) a na zlepšenie fyzickej funkcie. axiálne spondyloarthritisankylosing spondylitída (as)simponi je indikovaný na liečbu ťažkej, aktívnej ankylozujúcej spondylitíde u dospelých, ktorí reagovali neadekvátne konvenčná terapia. non radiographic axiálne spondyloarthritis (nr axiálne spa)simponi je indikovaný na liečbu dospelých pacientov s ťažkou, aktívne non radiographic axiálne spondyloarthritis objektívne príznaky zápalu, ako je uvedené zvýšenej c reaktívneho proteínu (crp) a/alebo magnetickou rezonanciou (mri) dôkazy, ktorí mali nedostatočnú odpoveď na, alebo netolerujú nesteroidné protizápalové lieky (nsaid). ulcerózna kolitída (uc)simponi je indikovaný na liečbu mierne až ťažkou aktívnou ulcerózna kolitída u dospelých pacientov, ktorí mali nedostatočnú odpoveď na konvenčnú liečbu vrátane kortikosteroidov a 6 mercaptopurine (6 mp) alebo azatioprin (aza), alebo ktorí netolerujú, alebo majú zdravotné kontraindikácie pre tieto terapie.

Եվրոպական Միություն - սլովակերեն - EMA (European Medicines Agency)

pfizer europe ma eeig - etanercept - arthritis, psoriatic; spondylitis, ankylosing; psoriasis - imunosupresíva - reumatoidná artritída;juvenilnej idiopatickej arthritispsoriatic artritída;axiálne spondyloarthritis;lupienky;pediatrické lupienky.

Եվրոպական Միություն - սլովակերեն - 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 - imunosupresíva - 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 bolo preukázané, že znižujú rýchlosť progresie poškodenia kĺbov, merané podľa x-ray a zlepšiť fyzickú funkciu, keď uvedené v kombinácii s metotrexátom. 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. adalimumab nebol skúmaný u pacientov vo veku menej ako 2 roky. 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. 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 bolo preukázané, že znižujú rýchlosť progresie periférne poškodenie kĺbov, merané x-ray u pacientov s polyartikulárnou symetrické subtypes ochorenia (pozri časť 5. 1) a na zlepšenie fyzickej funkcie. 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 a 5. 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.

Եվրոպական Միություն - սլովակերեն - 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 - imunosupresíva - 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 bolo preukázané, že znižujú rýchlosť progresie poškodenia kĺbov, merané podľa x-ray a zlepšiť fyzickú funkciu, keď uvedené v kombinácii s metotrexátom. 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 nebol skúmaný u pacientov vo veku menej ako 2 roky. 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 bolo preukázané, že znižujú rýchlosť progresie periférne poškodenie kĺbov, merané x-ray u pacientov s polyartikulárnou symetrické subtypes ochorenia a zlepšiť telesné funkcie. 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 a 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.