欧盟 - 斯洛伐克文 - EMA (European Medicines Agency)

teva b.v. - leflunomid - arthritis, rheumatoid; arthritis, psoriatic - imunosupresíva - leflunomid je indikovaný na liečbu dospelých pacientov s aktívnou reumatoidnou artritídou ako "chorobu modifikujúce antirheumatic drog" (dmard);aktívnou psoriatickou artritídou. nedávne alebo súbežná liečba s hepatotoxic alebo haematotoxic dmards (e. metotrexát) môže mať za následok zvýšené riziko závažných nežiaducich účinkov; preto sa musí starostlivo zvážiť začatie liečby leflunomidom, pokiaľ ide o tieto aspekty prínos / riziko. navyše, prechod z leflunomid na iný dmard bez nadväznosti na vymývanie postup tiež môže zvýšiť riziko závažných nežiaducich reakcií, aj dlhý čas po prepnutí.

欧盟 - 斯洛伐克文 - EMA (European Medicines Agency)

alexion europe sas - eculizumab - hemoglobinúria, paroxysmálna - imunosupresíva - soliris je indikovaný u dospelých a detí na liečbu:paroxyzmálna nočné haemoglobinuria (pnh). dôkazy z klinických výhodou je preukázaná u pacientov s haemolysis s klinický príznak(s) svedčí o vysokej aktivity ochorenia, bez ohľadu na transfúziu históriu (pozri časť 5. atypické haemolytic-uremickým syndrómom (zariadenia). soliris je indikovaný u dospelých na liečbu:Žiaruvzdorné generalizované myasthenia gravis (gmg) u pacientov, ktorí sú anti-acetylcholínové receptory (achr) protilátky-pozitívne (pozri časť 5. neuromyelitis optica spektrum poruchy (nmosd) u pacientov, ktorí sú anti-aquaporin-4 (aqp4) protilátky-pozitívne s relapsujúcou priebeh ochorenia.

欧盟 - 斯洛伐克文 - EMA (European Medicines Agency)

ucb pharma s.a.   - bimekizumab - svrab - imunosupresíva - plaque psoriasisbimzelx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. psoriatic arthritisbimzelx, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (dmards). axial spondyloarthritisnon-radiographic axial spondyloarthritis (nr-axspa)bimzelx is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs (nsaids). ankylosing spondylitis (as, radiographic axial spondyloarthritis)bimzelx is indicated for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy.

欧盟 - 斯洛伐克文 - EMA (European Medicines Agency)

mylan ireland limited - fingolimod hydrochlorid - roztrúsená skleróza, recidivujúce-odosielajúcej - imunosupresíva - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older:patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 a 5. 1)orpatients s rýchlo sa meniacim ťažké recidivujúce odosielajúcej roztrúsená skleróza definovaná 2 alebo viac vypnutie relapsami v jednom roku, a s 1 alebo viac gadolínium zvýšenie lézie v mozgu mri alebo významný nárast v t2 lézií zaťažení v porovnaní s predchádzajúcim posledných mri.

欧盟 - 斯洛伐克文 - EMA (European Medicines Agency)

mylan ireland limited - fingolimod hydrochlorid - roztrúsená skleróza, recidivujúce-odosielajúcej - imunosupresíva - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 a 5. 1) or patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

欧盟 - 斯洛伐克文 - EMA (European Medicines Agency)

accord healthcare s.l.u. - teriflunomide - roztrúsená skleróza, recidivujúce-odosielajúcej - imunosupresívami, selektívne imunosupresívami - teriflunomide accord is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 for important information on the population for which efficacy has been established).

欧盟 - 斯洛伐克文 - EMA (European Medicines Agency)

pfizer europe ma eeig - tofacitinib - artritída, reumatoidná artritída - imunosupresíva - rheumatoid arthritistofacitinib in combination with methotrexate (mtx) is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (dmards) (see section 5. tofacitinib can be given as monotherapy in case of intolerance to mtx or when treatment with mtx is inappropriate (see sections 4. 4 a 4. psoriatic arthritistofacitinib in combination with mtx is indicated for the treatment of active psoriatic arthritis (psa) in adult patients who have had an inadequate response or who have been intolerant to a prior disease modifying antirheumatic drug (dmard) therapy (see section 5. ulcerative colitistofacitinib 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 (see section 5. tofacitinib is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive [rf+] or negative [rf-] polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis (psa) in patients 2 years of age and older, who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (dmards). tofacitinib can be given in combination with methotrexate (mtx) or as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. ankylosing spondylitistofacitinib is indicated for the treatment of adult patients with active ankylosing spondylitis (as) who have responded inadequately to conventional therapy.

欧盟 - 斯洛伐克文 - EMA (European Medicines Agency)

janssen-cilag international n.v.    - ponesimod - roztrúsená skleróza, recidivujúce-odosielajúcej - imunosupresíva - ponvory is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features.

欧盟 - 斯洛伐克文 - EMA (European Medicines Agency)

mylan pharmaceuticals limited - teriflunomide - roztrúsená skleróza, recidivujúce-odosielajúcej - imunosupresíva - teriflunomide mylan is indicated for the treatment of adult patients and paediatric patients aged 10 years and older (body weight > 40 kg) with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 of the smpc for important information on the population for which efficacy has been established).

欧盟 - 斯洛伐克文 - EMA (European Medicines Agency)

ucb pharma sa  - certolizumab pegol - artritída, reumatoidná artritída - imunosupresíva - reumatoidná arthritiscimzia, v kombinácii s metotrexátom (mtx), je indikovaný na:liečbu stredne ťažkej, aktívnej reumatoidnej artritídy (ra) u dospelých pacientov, keď reakcia na ochorenie-úprava antirheumatic drugs (dmards) vrátane mtx, bola neprimeraná. cimzia sa môže podávať ako monotherapy pri intolerancii mtx alebo keď pokračovanie liečby s mtx je inappropriatethe liečbu ťažkej, aktívnej a progresívnej ra u dospelých, ktoré predtým neboli liečení mtx alebo iných dmards. cimzia bolo preukázané, že znižujú rýchlosť progresie poškodenia kĺbov merané x ray a zlepšiť fyzickú funkciu, keď uvedené v kombinácii s mtx. axiálne spondyloarthritis cimzia je indikovaný na liečbu dospelých pacientov s ťažkou aktívnou axiálne spondyloarthritis, ktoré zahŕňajú:ankylozujúca spondylitída (as)dospelých pacientov s ťažkou aktívnou ankylozujúcou spondylitídou, ktorí mali nedostatočnú odpoveď na, alebo netolerujú nesteroidné protizápalové lieky (nsaid). axiálne spondyloarthritis bez radiographic dôkaz asadults s ťažkým aktívn