Europska Unija - slovenski - EMA (European Medicines Agency)

argenx - efgartigimod alfa - myasthenia gravis - imunosupresivi - vyvgart is indicated as an add on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gmg) who are anti acetylcholine receptor (achr) antibody positive.

Europska Unija - slovenski - 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.

Europska Unija - slovenski - EMA (European Medicines Agency)

pfizer europe ma eeig - topotekan - uterine cervical neoplasms; small cell lung carcinoma - drugi antineoplastiki - monoterapija s topotekanom je indicirana za zdravljenje bolnikov z relapsom drobnoceličnega pljučnega raka (sclc), pri katerih se ponovno zdravljenje z režimom prve linije ne šteje za primerno. topotecan v kombinaciji z cisplatin je indicirano za bolnike z karcinom materničnega vratu periodično po radioterapija in za bolnike z stadiju ivb bolezni. bolniki s predhodno izpostavljenosti cisplatin zahtevajo trajno zdravljenje-prosti interval, da se upraviči zdravljenje s kombinacijo.

Europska Unija - slovenski - EMA (European Medicines Agency)

incyte biosciences distribution b.v. - tafasitamab - lymphoma, large b-cell, diffuse - antineoplastična sredstva - minjuvi is indicated in combination with lenalidomide followed by minjuvi monotherapy for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) who are not eligible for autologous stem cell transplant (asct).

Europska Unija - slovenski - EMA (European Medicines Agency)

sanofi b.v. - olipudase alfa - acid sphingomyelinase deficiency (asmd) type a/b or type b - drugi zdravljene bolezni prebavil in presnove izdelki, - xenpozyme is indicated as an enzyme replacement therapy for the treatment of non-central nervous system (cns) manifestations of acid sphingomyelinase deficiency (asmd) in paediatric and adult patients with type a/b or type b.

Europska Unija - slovenski - 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.

Europska Unija - slovenski - 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 .

Europska Unija - slovenski - 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.

Europska Unija - slovenski - 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.

Europska Unija - slovenski - EMA (European Medicines Agency)

actavis group ptc ehf - topotekan - uterine cervical neoplasms; small cell lung carcinoma - antineoplastična sredstva - topotecan monotherapy is indicated for the treatment of:- patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy- patients with relapsed small cell lung cancer (sclc) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5. topotecan v kombinaciji z cisplatin je indicirano za bolnike z karcinom materničnega vratu periodično po radioterapija in za bolnike z stadiju ivb bolezni. patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination (see section 5.