Unjoni Ewropea - Sloven - EMA (European Medicines Agency)

laboratoire francais du fractionnement et des biotechnologies - antithrombin alfa - pomanjkanje antitrombina iii - antitrombotična sredstva - atryn je indiciran za profilakso venske tromboembolije pri operaciji bolnikov s prirojeno pomanjkanjem antitrombina. zdravilo atryn se običajno daje v povezavi s heparinom ali heparinom z nizko molekularno težo.

Unjoni Ewropea - Sloven - EMA (European Medicines Agency)

correvio - vernakalant hidroklorid - atrijska fibrilacija - srčna terapija - hitro pretvorbo nedavni nastop atrijsko fibrilacijo, da sinus ritem pri odraslih:za ne-operaciji bolniki: atrijska fibrilacija .

Unjoni Ewropea - Sloven - EMA (European Medicines Agency)

pfizer europe ma eeig - anidulafungin - kandidoza - antimikotiki za sistemsko uporabo - zdravljenje invazivne kandidoze pri odraslih in pediatričnih bolnikih, starih od 1 meseca do < 18 let.

Unjoni Ewropea - Sloven - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - elotuzumab - multiple myeloma - antineoplastična sredstva - empliciti je navedeno v kombinaciji z lenalidomide in dexamethasone za zdravljenje več plazmocitom pri odraslih bolnikih, ki so prejeli vsaj eno predhodno zdravljenje (glej točki 4. 2 in 5.

Unjoni Ewropea - Sloven - EMA (European Medicines Agency)

les laboratoires servier - irinotecan anhydrous free-base - pankreatične neoplazme - antineoplastična sredstva - zdravljenje metastatskega adenokarcinoma trebušne slinavke, v kombinaciji z 5 flúorouracíl (5-fu) in leucovorin (lv), pri odraslih bolnikih, ki so napredovali po gemcitabin na zdravljenje.

Unjoni Ewropea - Sloven - EMA (European Medicines Agency)

astrazeneca ab - anifrolumab - lupus erythematosus, sistemski - imunosupresivi - saphnelo is indicated as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (sle), despite standard therapy.

Unjoni Ewropea - Sloven - EMA (European Medicines Agency)

novartis europharm limited - tislelizumab - esophageal squamous cell carcinoma - antineoplastična sredstva - oesophageal squamous cell carcinoma (oscc) tevimbra as monotherapy is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma after prior platinum-based chemotherapy.

Unjoni Ewropea - Sloven - 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.

Unjoni Ewropea - Sloven - EMA (European Medicines Agency)

takeda pharma a/s - vedolizumab - colitis, ulcerative; crohn disease - selektivni imunosupresivi - ulcerozni colitisentyvio je indiciran za zdravljenje odraslih bolnikov z zmerno do močno aktivnim ulceroznim kolitisom, ki so imeli neustreznega odziva, izgubil odgovor da, ali so bili nestrpni, da bodisi konvencionalne terapije ali tumor nekroze faktor alfa (tnfa) antagonist. crohnova diseaseentyvio je indiciran za zdravljenje odraslih bolnikov z zmerno do hudo aktivno crohnovo boleznijo, ki so imeli neustreznega odziva, izgubil odgovor da, ali so bili nestrpni, da bodisi konvencionalne terapije ali tumor nekroze faktor alfa (tnfa) antagonist. pouchitisentyvio is indicated for the treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy.

Unjoni Ewropea - Sloven - EMA (European Medicines Agency)

sanofi b.v. - alglukozidaza alfa - bolezen tipa ii za shranjevanje glikogena - drugi zdravljene bolezni prebavil in presnove izdelki, - myozyme je indiciran za dolgoročno encimsko nadomestno zdravljenje (ert) pri bolnikih s potrjeno diagnozo pompejeve bolezni (pomanjkanje kisline-α-glukozidaze). pri bolnikih s poznim nastopom pompe bolezni dokazov o učinkovitosti, je omejeno.