Evropská unie - čeština - 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 - imunosupresiva - 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. adalimumabu bylo prokázáno, že snižuje rychlost progrese kloubního poškození měřeného pomocí rtg a že zlepšuje fyzické funkce, pokud je podáván v kombinaci s methotrexátem. 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 nebyl zkoumán u pacientů ve věku méně než 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. adalimumabu bylo prokázáno snížení rychlosti progrese poškození periferních kloubů, měřeno pomocí rtg u pacientů se symetrickým polyartikulárním subtypem onemocnění a zlepšení tělesné funkce. 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.

Česká republika - čeština - USKVBL (Ústav Pro Státní Kontrolu Veterinárních Biopreparátů A Léčiv)

bioveta, a.s. - tuberkulín - injekce - 28000iu/ml - diagnostika tuberkulózy - drůbež, skot, prasata

Česká republika - čeština - USKVBL (Ústav Pro Státní Kontrolu Veterinárních Biopreparátů A Léčiv)

bioveta, a.s. - tuberkulín - injekční roztok - diagnostika tuberkulózy - skot, ovce, kozy, prasata, koně, psi

Evropská unie - čeština - EMA (European Medicines Agency)

sandoz gmbh - adalimumab - spondylitis, ankylosing; hidradenitis suppurativa; psoriasis; arthritis, juvenile rheumatoid; uveitis - imunosupresiva - rheumatoid arthritishefiya 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. léčbě závažné, aktivní a progresivní revmatoidní artritidy u dospělých, kteří nebyli předtím léčeni methotrexátem. hefiya can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. adalimumabu bylo prokázáno, že snižuje rychlost progrese kloubního poškození měřeného pomocí rtg a že zlepšuje fyzické funkce, pokud je podáván v kombinaci s methotrexátem. juvenilní idiopatická arthritispolyarticular juvenilní idiopatické artritidy hefiya v kombinaci s methotrexátem je indikován k léčbě aktivní polyartikulární juvenilní idiopatické artritidy u pacientů od 2 let věku, kteří měli nedostatečnou odpověď na léčbu jedním nebo více nemoc modifikujícími antirevmatickými léky (dmard). hefiya může být podáván jako monoterapie v případě intolerance methotrexátu, nebo kdy pokračování v léčbě methotrexátem není vhodné (pro účinnost v monoterapii viz bod 5. adalimumab nebyl zkoumán u pacientů ve věku méně než 2 roky. související s enthesitis artritidy hefiya je indikován k léčbě aktivní související s enthesitis artritidy u pacientů ve věku 6 let a starších, kteří měli nedostatečnou odpověď nebo kteří netolerují konvenční léčbu (viz bod 5. axiální spondyloarthritisankylosing spondylitidy (as) hefiya je indikován k léčbě dospělých pacientů s těžkou aktivní ankylozující spondylitidou, u kterých nebyla dostatečná odpověď na konvenční léčbu. axiální spondylartritidy bez rentgenový nález jako hefiya je indikován k léčbě dospělých se závažnou axiální spondylartritidy bez radiografické důkazy o as, ale s objektivními známkami zánětu tím, že zvýšené crp a / nebo mri, kteří vykazovali nepřiměřenou reakci nebo nesnášenlivost na nesteroidní protizánětlivé léky. psoriatická arthritishefiya je indikován k léčbě aktivní a progresivní psoriatické artritidy u dospělých, pokud odpověď na předchozí léčbu chorobu modifikujícím antirevmatickým přípravkem nebyla dostatečná. adalimumabu bylo prokázáno snížení rychlosti progrese poškození periferních kloubů, měřeno pomocí rtg u pacientů se symetrickým polyartikulárním subtypem onemocnění (viz bod 5. 1) a zlepšení fyzických funkcí. psoriasishefiya je indikován k léčbě středně těžké až těžké chronické ložiskové psoriázy u dospělých pacientů, kteří jsou kandidáty pro systémovou léčbu. ložiskové psoriasishefiya je indikován k léčbě těžké chronické ložiskové psoriázy u dětí a dospívajících od 4 let věku, kteří vykazovali nepřiměřenou reakci nebo jsou nevhodné kandidáty pro lokální terapii a phototherapies. ložiskové psoriasishefiya je indikován k léčbě těžké chronické ložiskové psoriázy u dětí a dospívajících od 4 let věku, kteří vykazovali nepřiměřenou reakci nebo jsou nevhodné kandidáty pro lokální terapii a phototherapies. hidradenitis suppurativa (hs)hefiya 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 diseasehefiya 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 diseasehefiya 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. paediatric ulcerative colitishefiya 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.  ulcerative colitis hefiya 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 hefiya 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 uveitis hefiya 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.

Evropská unie - čeština - EMA (European Medicines Agency)

sandoz gmbh - adalimumab - arthritis, rheumatoid; arthritis, psoriatic; spondylitis, ankylosing; uveitis; hidradenitis suppurativa; colitis, ulcerative; arthritis, juvenile rheumatoid; crohn disease; skin diseases, papulosquamous - imunosupresiva - rheumatoid arthritishyrimoz 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 může být podáván jako monoterapie v případě intolerance methotrexátu, nebo kdy pokračování v léčbě methotrexátem není vhodné. adalimumabu bylo prokázáno, že snižuje rychlost progrese kloubního poškození měřeného pomocí rtg a že zlepšuje fyzické funkce, pokud je podáván v kombinaci s methotrexátem. juvenile idiopathic arthritis- polyarticular juvenile idiopathic arthritishyrimoz 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 může být podáván jako monoterapie v případě intolerance methotrexátu, nebo kdy pokračování v léčbě methotrexátem není vhodné. adalimumab nebyl zkoumán u pacientů ve věku méně než 2 roky. - enthesitis-related arthritishyrimoz 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- ankylosing 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 ashyrimoz 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 arthritishyrimoz 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. adalimumabu bylo prokázáno snížení rychlosti progrese poškození periferních kloubů, měřeno pomocí rtg u pacientů se symetrickým polyartikulárním subtypem onemocnění a zlepšení tělesné funkce. psoriasishyrimoz is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasishyrimoz 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 diseasehyrimoz 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 diseasehyrimoz 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.  paediatric ulcerative colitishyrimoz 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. ulcerative colitishyrimoz 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. uveitishyrimoz 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 uveitishyrimoz 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.

Evropská unie - čeština - 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 - imunosupresiva - 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. adalimumabu bylo prokázáno, že snižuje rychlost progrese kloubního poškození měřeného pomocí rtg a že zlepšuje fyzické funkce, pokud je podáván v kombinaci s methotrexátem. 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. adalimumab nebyl zkoumán u pacientů ve věku méně než 2 roky. 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. 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. adalimumabu bylo prokázáno snížení rychlosti progrese poškození periferních kloubů, měřeno pomocí rtg u pacientů se symetrickým polyartikulárním subtypem onemocnění (viz bod 5. 1) a zlepšení fyzických funkcí. 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 a 5. 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.

Česká republika - čeština - SUKL (Státní ústav pro kontrolu léčiv)

viatris limited, dublin array - 8939 leflunomid - potahovaná tableta - 20mg - leflunomid

Česká republika - čeština - SUKL (Státní ústav pro kontrolu léčiv)

pfizer, spol. s r.o., praha array - 2430 natrium-methylprednisolon-sukcinÁt - prášek a rozpouštědlo pro injekční roztok - 40mg/ml - methylprednisolon

Česká republika - čeština - SUKL (Státní ústav pro kontrolu léčiv)

pfizer, spol. s r.o., praha array - 2430 natrium-methylprednisolon-sukcinÁt - prášek a rozpouštědlo pro injekční roztok - 62,5mg/ml - methylprednisolon

Evropská unie - čeština - EMA (European Medicines Agency)

teva b.v. - leflunomid - arthritis, rheumatoid; arthritis, psoriatic - imunosupresiva - leflunomid je indikován k léčbě dospělých pacientů s aktivní revmatoidní artritidou jako tzv. chorobu modifikující antirevmatika léčiva (dmard);aktivní psoriatickou artritidou. nedávná nebo současná léčba hepatotoxickými nebo hematotoxických dmard (e. methotrexát) může vést ke zvýšenému riziku závažných nežádoucích účinků; proto je třeba pečlivě zvážit zahájení léčby leflunomidem vzhledem k těmto aspektům přínosu a rizika. navíc převedení z leflunomidu na jiné dmard bez následné tzv. eliminační kúry může také zvýšit riziko vážných nežádoucích účinků dokonce i za dlouhou dobu po převedení.