Euroopa Liit - sloveeni - EMA (European Medicines Agency)

genzyme europe bv - sevelamerijev klorid - hyperphosphatemia; renal dialysis - vsi drugi terapevtski izdelki - tasermity je indicirano za nadzor nad hyperphosphataemia pri odraslih bolnikih, ki prejemajo hemodializni ali peritonealno dializo. sevelamer hidroklorid uporabljati v okviru več terapevtski pristop, ki bi lahko vključevali kalcija, 1,25-dihidroksi vitamina d3 ali eden od njegovih analogov, za nadzor nad razvojem bolezni ledvic kosti.

Euroopa Liit - sloveeni - EMA (European Medicines Agency)

astrazeneca ab - metformin hidroklorid, saxagliptin, dapagliflozin - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - qtrilmet je navedeno pri odraslih, starih 18 let in več, z vrsto 2 sladkorna bolezen:za izboljšanje glycaemic nadzora, ko je z metforminom ali brez sulfonil sečnine (su) in bodisi saxagliptin ali dapagliflozin ne zagotavlja primerne glycaemic nadzor. ko se že zdravijo z metforminom in saxagliptin in dapagliflozin.

Euroopa Liit - sloveeni - EMA (European Medicines Agency)

accord healthcare s.l.u. - sitagliptin hydrochloride - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - for adult patients with type 2 diabetes mellitus, sitagliptin accord is indicated to improve glycaemic control:as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. - a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance. - a peroxisome proliferator-activated receptor gamma (ppary) agonist (i. a thiazolidinedione) when use of a ppary agonist is appropriate and when diet and exercise plus the ppary agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. - a ppary agonist and metformin when use of a ppary agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. sitagliptin accord is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Euroopa Liit - sloveeni - EMA (European Medicines Agency)

oncopeptides ab - melphalan flufenamide hydrochloride - multiple myeloma - antineoplastična sredstva - pepaxti is indicated, in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-cd38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. for patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation (see section 4.

Euroopa Liit - sloveeni - EMA (European Medicines Agency)

neovii biotech gmbh - catumaxomab - ascites; cancer - drugi antineoplastiki - removab je indiciran za intraperitonealno zdravljenje malignih ascitesov pri bolnikih s pozitivnimi karcinomom epcam, pri katerih standardna terapija ni na voljo ali ni več izvedljiva.

Euroopa Liit - sloveeni - EMA (European Medicines Agency)

biomarin international limited - sapropterin dihydrochloride - fenilketonurije - drugi zdravljene bolezni prebavil in presnove izdelki, - kuvan je indiciran za zdravljenje hiperfenilalaninemije (hpa) pri odraslih in pediatričnih bolnikih vseh starosti s fenilketonurijo (pku), za katere se je izkazalo, da so odzivne na takšno zdravljenje. kuvan je tudi primerna za zdravljenje hyperphenylalaninaemia (hpa) pri odraslih in pediatričnih bolnikih vseh starosti z tetrahydrobiopterin (bh4) pomanjkljivosti, ki so pokazale, da se je treba odzivati na tako zdravljenje.

Euroopa Liit - sloveeni - EMA (European Medicines Agency)

gmp-orphan sa - trientine tetrahydrochloride - hepatolentikularna degeneracija - drugi zdravljene bolezni prebavil in presnove izdelki, - cuprior je primerna za zdravljenje wilsonova bolezen pri odraslih, mladostnikih in otrocih, ≥ 5 let nestrpni do d-penicillamine terapija.

Euroopa Liit - sloveeni - EMA (European Medicines Agency)

bristol myers squibb pharma eeig - fedratinib dihydrochloride monohydrate - myeloproliferative disorders; primary myelofibrosis - antineoplastična sredstva - inrebic is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis who are janus associated kinase (jak) inhibitor naïve or have been treated with ruxolitinib.

Euroopa Liit - sloveeni - EMA (European Medicines Agency)

novartis europharm limited  - capmatinib dihydrochloride monohydrate - karcinom, pljučni pljuč - antineoplastična sredstva - tabrecta as monotherapy is indicated for the treatment of adult patients with advanced non small cell lung cancer (nsclc) harbouring alterations leading to mesenchymal epithelial transition factor gene exon 14 (metex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum based chemotherapy.

Euroopa Liit - sloveeni - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - quizartinib dihydrochloride - leukemija, myeloid - antineoplastic agents, protein kinase inhibitors - vanflyta is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by vanflyta single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia (aml) that is flt3-itd positive.