Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - azacitidin - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastična sredstva - azacitidine soglasju je indicirano za zdravljenje odraslih bolnikih, ki niso primerni za haematopoietic stem cell presaditev (hsct) z:- intermediate-2 in visokim tveganjem myelodysplastic sindromov (mds) je v skladu z mednarodnim prognostic sistem točkovanja (ipss),- kronično myelomonocytic levkemijo (cmml) z 10-29 % mozga eksplozije brez myeloproliferative motnje,- akutno mieloično levkemijo (aml) z 20-30 % blastov in multi-rodbine displazija, po ocenah svetovne zdravstvene organizacije (who), in razvrščanje,- aml s >30% mozgu eksplozije glede na razvrstitev, ki.

Evropska unija - slovenščina - EMA (European Medicines Agency)

nova laboratories ireland limited - azathioprine - zavrnitev presadka - imunosupresivi - jayempi is indicated in combination with other immunosuppressive agents for the prophylaxis of transplant rejection in patients receiving allogenic kidney, liver, heart, lung or pancreas transplants. azathioprine is indicated in immunosuppressive regimens as an adjunct to immunosuppressive agents that form the mainstay of treatment (basis immunosuppression). jayempi is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and/ or procedures which influence the immune response. jayempi is indicated in patients who are intolerant to glucocorticosteroids or if the therapeutic response is inadequate despite treatment with high doses of glucocorticosteroids, in the following diseases:severe active rheumatoid arthritis (chronic polyarthritis) that cannot be kept under control by less toxic agents (disease-modifying anti-rheumatic -medicinal products – dmards)auto-immune hepatitis systemic lupus erythematosusdermatomyositispolyarteritis nodosapemphigus vulgaris and bullous pemphigoidbehçet’s diseaserefractory auto-immune haemolytic anaemia, caused by warm igg antibodieschronic refractory idiopathic thrombocytopenic purpurajayempi is used for the treatment of moderately severe to severe forms of chronic inflammatory bowel disease (ibd) (crohn’s disease or ulcerative colitis) in patients in whom glucocorticosteroid therapy is necessary, but where glucocorticosteroids are not tolerated, or in whom the disease is untreatable with other common means of first choice. it is also indicated in adult patients in relapsing multiple sclerosis, if an immunomodulatory therapy is indicated but beta interferon therapy is not possible, or a stable course has been achieved with previous treatment with azathioprine. 3jayempi is indicated for the treatment of generalised myasthenia gravis. depending on the severity of the disease, jayempi should be given in combination with glucocorticosteroids because of slow onset of action at the beginning of treatment and the glucocorticosteroid dose should be gradually reduced after several months of treatment.

Evropska unija - slovenščina - EMA (European Medicines Agency)

regeneron ireland designated activity company (dac) - cemiplimab - karcinoma, squamous cell - antineoplastična sredstva - cutaneous squamous cell carcinomalibtayo as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mcscc or lacscc) who are not candidates for curative surgery or curative radiation. basal cell carcinomalibtayo as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (labcc or mbcc) who have progressed on or are intolerant to a hedgehog pathway inhibitor (hhi). non-small cell lung cancerlibtayo as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (nsclc) expressing pd-l1 (in ≥ 50% tumour cells), with no egfr, alk or ros1 aberrations, who have:locally advanced nsclc who are not candidates for definitive chemoradiation, ormetastatic nsclc. libtayo in combination with platinum‐based chemotherapy is indicated for the first‐line treatment of adult patients with nsclc expressing pd-l1 (in ≥ 1% of tumour cells), with no egfr, alk or ros1 aberrations, who have:locally advanced nsclc who are not candidates for definitive chemoradiation, ormetastatic nsclc. cervical cancerlibtayo as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.

Evropska unija - slovenščina - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab, relatlimab - melanoma - antineoplastic agents, monoclonal antibodies - opdualag is indicated for the first line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell pd l1 expression < 1%.

Evropska unija - slovenščina - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - belatacept - graft rejection; kidney transplantation - imunosupresivi - nulojix, in combination with corticosteroids and a mycophenolic acid (mpa), is indicated for prophylaxis of graft rejection in adult recipients of a renal transplant.

Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - vorikonazol - aspergillosis; candidiasis; mycoses - antimycotics za sistemsko uporabo, triazol derivati - voriconazole je v širokem spektru, triazol protiglivično sredstvo, ter je označena pri odraslih in otrocih, starih dve leti ali več, kot sledi:zdravljenje invazivne aspergillosis;zdravljenje candidaemia v ne-neutropenic bolnikov;zdravljenje fluconazole-odporne resno invazivne candida okužbe (vključno c. krusei);zdravljenje hude glivične okužbe, ki jih povzročajo scedosporium spp. in oxysporum spp. voriconazole soglasju mora biti urejen, predvsem pri bolnikih z napredujočo, morda celo smrtno nevarne okužbe.

Evropska unija - slovenščina - EMA (European Medicines Agency)

olympus biotech international limited - eptotermin alfa - tibialni zlomi - zdravila za zdravljenje bolezni kosti, bone morphogenetic beljakovin - zdravljenje nonunion golenico traja vsaj 9 mesecev, sekundarni travme, v skeletally zrel bolnikov, v primerih, kjer ni uspela predhodno zdravljenje z autograft ali uporabo autograft je neizvedljivo.

Evropska unija - slovenščina - EMA (European Medicines Agency)

pfizer europe ma eeig - sirolimus - graft rejection; kidney transplantation - imunosupresivi - zdravilo rapamune je indicirano za profilakso zavrnitve organa pri odraslih bolnikih z majhnim do zmernim imunskim tveganjem, ki prejemajo presaditev ledvic. priporočljivo je, da rapamune uporablja sprva v kombinaciji z ciclosporin microemulsion in kortikosteroidi za 2 do 3 mesece. rapamune lahko nadaljeval, kot vzdrževalna terapija s kortikosteroidi le, če ciclosporin microemulsion lahko postopno opuščeni. rapamune je indiciran za zdravljenje bolnikov z občasno lymphangioleiomyomatosis z zmerno boleznijo pljuč ali upada pljučne funkcije.

Evropska unija - slovenščina - EMA (European Medicines Agency)

novartis europharm limited - baziliksimab - graft rejection; kidney transplantation - imunosupresivi - simulect je indiciran za profilakso akutnega zavrnitve organa pri de-novem allogensko presaditvi ledvic pri odraslih in pediatričnih bolnikih (1-17 let). to je treba uporabiti hkrati z ciclosporin za microemulsion - in kortikosteroidi, ki temelji imunosupresija, pri bolnikih s ploščo reaktivnih protiteles manj kot 80%, ali v trojni vzdrževanje imunosupresivna režim, ki vsebujejo ciclosporin za microemulsion, kortikosteroidi in azatioprina ali mofetilmikofenolata.

Evropska unija - slovenščina - EMA (European Medicines Agency)

pfizer europe ma eeig - vorikonazol - candidiasis; mycoses; aspergillosis - antimikotiki za sistemsko uporabo - voriconazole, je širok spekter, triazol protiglivično sredstvo, ter je označena pri odraslih in otrocih, starih 2 leti in več, kot sledi:zdravljenje invazivne aspergillosis;zdravljenje v candidaemianon-neutropenic bolnikov;zdravljenje fluconazole-odporne resno invazivne candida okužbe (vključno c. krusei);zdravljenje hude glivične okužbe, ki jih povzročajo scedosporium spp. in oxysporum spp. vfend je treba preskusiti, predvsem pri bolnikih z napredujočo, morda celo smrtno nevarne okužbe. profilaksa invazivnih glivičnih okužb v visoko tveganje allogeneic hematopoietic matičnih celic za presajanje (hsct) prejemniki.