Evropska unija - slovenščina - EMA (European Medicines Agency)

therakind (europe) limited - metotreksat - arthritis, psoriatic; precursor cell lymphoblastic leukemia-lymphoma; psoriasis; arthritis, rheumatoid; arthritis - antineoplastična sredstva - v rheumatological in dermatološki diseasesactive revmatoidni artritis pri odraslih bolnikih,. polyarthritic oblike aktivno, hudo mladoletnike idiopatsko artritis (jia) pri mladostnikih in otrocih, starih 3 leta in več, ko je odgovor, da nesteroidna protivnetna zdravila (nesteroidnih protivnetnih zdravil), je bil neustrezen. hudo, zdravljenje-ognjevarni, onemogočanje luskavica, ki se ne odziva dovolj na druge oblike zdravljenja, kot so fototerapijo, psoralen in ultravijolično sevanje (puva) terapija in retinoidi, in hudo psoriatičnega artritisa pri odraslih bolnikih,. v oncologymaintenance zdravljenje acute lymphoblastic levkemijo (all) pri odraslih, mladostnikih in otrocih, starih 3 leta in več.

Evropska unija - slovenščina - EMA (European Medicines Agency)

theravia - holinska kislina - digestive system diseases; metabolism, inborn errors - Žolčnih kislin in derivati - orphacol je indicirano za zdravljenje prirojenih napak v primarni sintezo žolčnih kislin zaradi oxidoreductase 3β-hidroksi-Δ5-c27-steroid pomanjkljivost ali Δ4-3-oxosteroid-5β-reduktazo pomanjkljivost pri dojenčkih, otrocih in mladostnikih v starosti enega meseca do 18 let in odrasli.

Evropska unija - slovenščina - EMA (European Medicines Agency)

glaxosmithkline trading services limited - albiglutide - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - eperzan je primerna za zdravljenje diabetesa tipa 2 bolezni v odrasli za izboljšanje glycaemic nadzor:monotherapywhen dieto in telesno vadbo sam ne zagotavljajo ustrezne glycaemic nadzor pri bolnikih, za katere uporabo metformin je neprimerno zaradi kontraindikacije ali nestrpnosti. add-on kombinacija therapyin kombinaciji z drugimi glukoze-znižanje medicini, vključno z bazalni insulin, ko ti, skupaj z dieto in telesno vadbo, ne zagotavljajo ustrezne glycaemic nadzor (glej razdelek 4. 4 in 5. 1 za razpoložljive podatke o različnih kombinacijah).

Evropska unija - slovenščina - EMA (European Medicines Agency)

amgen europe b.v. - adalimumab - arthritis, psoriatic; colitis, ulcerative; arthritis, juvenile rheumatoid; spondylitis, ankylosing; psoriasis; crohn disease; arthritis, rheumatoid - imunosupresivi - 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. , zdravljenje hude, aktivne in postopno revmatoidni artritis pri odraslih, ki še niso bila obdelana z metotreksatom. ,  amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. amgevita zmanjšuje stopnja napredovanje skupno škodo, merjeno z x-ray in izboljšuje telesno funkcijo, če bi imeli v kombinaciji z metotreksatom. 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 lahko podana kot monotherapy v primeru nestrpnost do metotreksatom ali ko nadaljnje zdravljenje z metotreksatom ni primerno (za učinkovitost v monotherapy glej oddelek 5. adalimumab ni raziskano pri bolnikih, starih manj kot 2 leti. 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 zmanjšuje stopnja napredovanje perifernih skupno škodo, merjeno z x-ray pri bolnikih z polyarticular simetrični podtipov bolezni (glej poglavje 5. 1), in izboljša telesno funkcijo. 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 in 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.

Evropska unija - slovenščina - EMA (European Medicines Agency)

theravia - hidroksikarbamid - anemija, srčna celica - antineoplastična sredstva - siklos je indicirano za preprečevanje ponavljajočih se boleče vaso-okluzivni krize, vključno z akutno prsih sindrom iz pediatrije in odraslih bolnikih, ki trpijo za simptomatsko anemija srpastih celic sindrom.

Evropska unija - slovenščina - EMA (European Medicines Agency)

novartis europharm limited - inclisiran - hypercholesterolemia; dyslipidemias - sredstva za spreminjanje lipidov - leqvio is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach ldl-c goals with the maximum tolerated dose of a statin, oralone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

Evropska unija - slovenščina - EMA (European Medicines Agency)

secura bio limited - duvelisib - leukemia, lymphocytic, chronic, b-cell; lymphoma, follicular - antineoplastična sredstva - copiktra monotherapy is indicated for the treatment of adult patients with: relapsed or refractory chronic lymphocytic leukaemia (cll) after at least two prior therapies.  follicular lymphoma (fl) that is refractory to at least two prior  systemic therapies.

Evropska unija - slovenščina - EMA (European Medicines Agency)

theravia - deksametazon - multiple myeloma - kortikosteroidi za sistemsko uporabo - zdravljenje večkratnega mieloma.

Evropska unija - slovenščina - EMA (European Medicines Agency)

pfizer europe ma eeig - levetiracetam - epilepsija - antiepileptics, - levetiracetam hospira je označen kot monoterapije pri zdravljenju zasegov delno nastopa z ali brez sekundarnega posplošitev v odrasli in mladostniki, od 16 let z novo diagnosticirano epilepsijo. levetiracetam hospira je označen kot adjunctive therapyin zdravljenje delno nastop napadi z ali brez sekundarne posplošitev pri odraslih, mladostnikih in otrocih od 4 let z epilepsijo. pri zdravljenju myoclonic zasegov v odrasle in mladostnike od 12. leta starosti z mladoletnimi myoclonic epilepsijo. v zdravljenju primarne splošni tonik-clonic zasegov v odrasle in mladostnike od 12. leta starosti z idiopatsko splošnih epilepsijo. levetiracetam hospira koncentrat je alternativa za bolnike, ko ustni uprava je začasno ni izvedljivo,.

Evropska unija - slovenščina - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - predkroglomerna limfoblastna levkemija limfoma - antineoplastična sredstva - blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options. blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.