Európska únia - slovenčina - EMA (European Medicines Agency)

amgen europe b.v. - adalimumab - arthritis, psoriatic; colitis, ulcerative; arthritis, juvenile rheumatoid; spondylitis, ankylosing; psoriasis; crohn disease; arthritis, rheumatoid - imunosupresíva - rheumatoid arthritis  amgevita 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. , liečbu ťažkej, aktívnej a progresívnej reumatoidnej artritídy u dospelých, ktoré predtým neboli liečení metotrexátom. ,  amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. amgevita znižuje rýchlosť progresie poškodenia kĺbov, merané podľa x-ray a zlepšuje fyzické funkcie, keď uvedené v kombinácii s metotrexátom. juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis amgevita 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). amgevita môže byť daný ako monotherapy v prípade intolerancie na metotrexát, alebo keď pokračovanie liečby s metotrexátom nevhodné (pre účinnosť v monotherapy pozri časť 5. adalimumab nebol skúmaný u pacientov vo veku menej ako 2 roky. enthesitis-related arthritis amgevita 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 spondyloarthritis ankylosing spondylitis (as) amgevita 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 as amgevita 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. psoriatic arthritis amgevita 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. amgevita znižuje rýchlosť progresie periférne poškodenie kĺbov, merané x-ray u pacientov s polyartikulárnou symetrické subtypes ochorenia (pozri časť 5. 1) a zlepšuje fyzické funkcie. psoriasis amgevita is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasis amgevita 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) amgevita 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 disease amgevita 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 disease amgevita 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 colitis amgevita 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 amgevita 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 amgevita 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.

Európska únia - slovenčina - EMA (European Medicines Agency)

sandoz gmbh - somatropín - turner syndrome; prader-willi syndrome; dwarfism, pituitary - hypofýzové a hypotalamické hormóny a analógy - dojčatá, deti a adolescentsgrowth poruchy vzhľadom na nedostatočné vylučovanie rastového hormónu (gh). rast poruchy súvisiace s turner syndrome. rast poruchy súvisiace s chronickou nedostatočnosťou obličiek. rast poruchy (aktuálna výška štandard-odchýlka skóre (kbÚ) < -2. 5 a rodičovskej upravené kbÚ < -1) v krátkom deti / dospievajúcich narodené malé na gestačný vek (sga) s pôrodnou hmotnosťou a / alebo dĺžky pod -2 štandardné odchýlky (sds), ktorí sa nepodarilo zobraziť catch-up rastu (výšky, rýchlosti (hv) kbÚ < 0 v priebehu minulého roka) od štyroch rokov veku alebo neskôr. prader-willi syndróm (pws), pre zlepšenie rastu a zloženie tela. diagnóza pws je treba potvrdiť príslušné genetické testovanie. adultsreplacement terapia u dospelých pacientov s výrazné nedostatočnosťou rastového hormónu. pacienti s ťažkou nedostatočnosťou rastového hormónu v dospelosti sú definované ako pacientov so známym hypotalamus hypofýzy patológia a aspoň jeden známy nedostatok je hormón hypofýzy nie je prolaktín. títo pacienti by mali podstúpiť jednej dynamickej skúške s cieľom diagnostikovať alebo vylúčiť nedostatočnosťou rastového hormónu. u pacientov s detstva-nástup izolované gh nedostatok (žiadne dôkazy hypotalamus-hypofýza choroby alebo lebečnej ožiareniu), dve dynamické testy by mali byť odporúča, s výnimkou tých, ktoré majú nízky inzulín-ako-rastový faktor-i (igf-i) koncentrácie (kbÚ < -2), ktorý môže byť považovaný za jeden test. cut-off point dynamického testu by mali byť prísne.

Európska únia - slovenčina - EMA (European Medicines Agency)

theravia - kyselina cholová - digestive system diseases; metabolism, inborn errors - Žlčové kyseliny a ich deriváty - orphacol je indikovaný na liečbu vrodených porúch syntézy primárnych žlčových kyselín syntéze kvôli 3β-hydroxy-Δ5-c27-steroid glyfosátoxidoreduktázy laktázy alebo Δ4-3-oxosteroid-5β-reduktázy deficitom u dojčiat, detí a dospievajúcich vo veku od jedného mesiaca do 18 rokov a dospelí.

Európska únia - slovenčina - 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.

Európska únia - slovenčina - 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.

Európska únia - slovenčina - EMA (European Medicines Agency)

samsung bioepis nl b.v. - adalimumab - spondylitis, ankylosing; arthritis, rheumatoid; uveitis; colitis, ulcerative; psoriasis; arthritis, psoriatic; crohn disease; hidradenitis suppurativa; arthritis - imunosupresíva - reumatoidná arthritisimraldi v kombinácii s metotrexátom, je indikovaný na:liečbu stredne ťažkej, aktívnej reumatoidnej artritídy u dospelých pacientov, keď reakcia na ochorenie-úprava anti-reumatické lieky, vrátane metotrexát bola neprimeraná. na liečbu ťažkej, aktívnej a progresívnej reumatoidnej artritídy u dospelých, ktoré predtým neboli liečení metotrexátom. imraldi môže byť daný ako monotherapy v prípade intolerancie na metotrexát, alebo keď pokračovanie liečby s metotrexátom nevhodné. 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 arthritisimraldi 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). imraldi 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 arthritisimraldi 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)imraldi 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 asimraldi 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). psoriatická arthritisimraldi je indikovaná na liečbu aktívnej a progresívnej psoriatická artritída u dospelých, keď reakcia na predchádzajúce ochorenia-úprava anti-reumatické farmakoterapia bola neprimeraná. 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) a na zlepšenie fyzickej funkcie. psoriasisimraldi je indikovaný na liečbu stredne silnej až silnej chronickej ložiskovej psoriázy u dospelých pacientov, ktorí sú kandidátmi pre systémová terapia. detská doska psoriasisimraldi je indikovaný na liečbu ťažkej chronickej ložiskovej psoriázy u detí a dospievajúcich od 4 rokov veku, ktorí mali nedostatočnú odpoveď na alebo sú nevhodné kandidátov na aktuálne terapie a phototherapies. hidradenitis suppurativa (hs)imraldi 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. crohnova diseaseimraldi je indikovaný na liečbu mierne až ťažkou aktívnou crohnova choroba, u dospelých pacientov, ktorí neodpovedali napriek úplné a primerané priebehu terapie s kortikosteroidov a/alebo imunosupresívnych, alebo ktorí netolerujú, alebo majú zdravotné kontraindikácie pre tieto terapie. paediatric crohn's diseaseimraldi 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 haveulcerative colitisimraldi 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 mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. paediatric ulcerative colitisimraldi 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. uveitisimraldi 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 corticosteroidsparing, or in whomcorticosteroid treatment is inappropriate. paediatric uveitisimraldi 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.

Slovensko - slovenčina - ŠÚKL (Štátny ústav pre kontrolu liečiv)

b.braun melsungen ag, nemecko - aminokyseliny - 47 - diaetetica

Slovensko - slovenčina - ŠÚKL (Štátny ústav pre kontrolu liečiv)

sanofi winthrop industrie, francúzsko - kyselina valproová - 21 - antiepileptica, anticonvulsiva

Slovensko - slovenčina - ŠÚKL (Štátny ústav pre kontrolu liečiv)

fresenius kabi deutschland gmbh, nemecko - aminokyseliny, vrátane kombinácií s polypeptidmi - 87 - varia i

Slovensko - slovenčina - ŠÚKL (Štátny ústav pre kontrolu liečiv)

fresenius kabi ab, Švédsko - tukové emulzie - 76 - infundibilia