Evotaz Európska únia - slovinčina - EMA (European Medicines Agency)

evotaz

bristol-myers squibb pharma eeig - cobicistat, atazanavir - okužbe z virusom hiv - antivirusi za sistemsko uporabo - evotaz is indicated in combination with other antiretroviral medicinal products for the treatment of hiv-1 infected adults and adolescents (aged 12 years and older weighing at least 35 kg) without known mutations associated with resistance to atazanavir (see sections 4. 4 in 5.

Mircera Európska únia - slovinčina - EMA (European Medicines Agency)

mircera

roche registration gmbh - metoksi polietilen glikol-epoetin beta - anemia; kidney failure, chronic - antianemični preparati - treatment of symptomatic anaemia associated with chronic kidney disease (ckd) in adult patients (see section 5. treatment of symptomatic anaemia associated with chronic kidney disease (ckd) in paediatric patients from 3 months to less than 18 years of age who are converting from another erythropoiesis stimulating agent (esa) after their haemoglobin level was stabilised with the previous esa (see section 5.

Nucala Európska únia - slovinčina - EMA (European Medicines Agency)

nucala

glaxosmithkline trading services - mepolizumab - astma - zdravila za obstruktivne pljučne bolezni, - severe eosinophilic asthmanucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older. chronic rhinosinusitis with nasal polyps (crswnp)nucala is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe crswnp for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control. eosinophilic granulomatosis with polyangiitis (egpa)nucala is indicated as an add-on treatment for patients aged 6 years and older with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (egpa). hypereosinophilic syndrome (hes)nucala is indicated as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.

Tesavel Európska únia - slovinčina - EMA (European Medicines Agency)

tesavel

merck sharp & dohme b.v. - sitagliptin - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - za bolnike z tipa 2 sladkorna bolezen, tesavel je pokazala, da izboljšanje glycaemic nadzor:kot monotherapy:pri bolnikih, neustrezno nadzorovane z dieto in telesno vadbo sami in za katere metformin ni primeren zaradi kontraindikacije ali nestrpnosti;kot dvojno oralna terapija v kombinaciji z:metformin, ko dieto in telesno vadbo plus metformin sam ne zagotavljajo ustrezne glycaemic nadzor;sulfonil sečnine, ko dieto in telesno vadbo plus maksimalne dopustne odmerek sulfonil sečnine sam ne zagotavljajo ustrezne glycaemic nadzor in, če metformin ni primeren zaradi kontraindikacije ali nestrpnosti;a ppary agonist (i. a thiazolidinedione) pri uporabi ppary agonist je to primerno in ko dieto in telesno vadbo plus ppary agonist sam ne zagotavljajo ustrezne glycaemic nadzor;kot trojna oralna terapija v kombinaciji witha sulfonil sečnine in metforminom, ko dieto in telesno vadbo plus dvojno zdravljenje s temi zdravili ne zagotavljajo ustrezne glycaemic nadzor;peroksisomski-proliferator-activated-receptor-gama (ppary) agonist in metforminom pri uporabi ppary agonist je to primerno in ko dieto in telesno vadbo plus dvojno zdravljenje s temi zdravili ne zagotavljajo ustrezne glycaemic nadzor. tesavel je prikazano tudi kot dodajte na inzulinu (z metforminom ali brez), ko dieto in telesno vadbo plus stabilen odmerek insulina ne zagotavljajo ustrezne glycaemic nadzor.

Teysuno Európska únia - slovinčina - EMA (European Medicines Agency)

teysuno

nordic group b.v. - tegafur, gimeracil, oteracil - Želodne neoplazme - antineoplastična sredstva - teysuno is indicated in adults:- for the treatment of advanced gastric cancer when given in combination with cisplatin (see section 5. - as monotherapy or in combination with oxaliplatin or irinotecan, with or without bevacizumab, for the treatment of patients with metastatic colorectal cancer for whom it is not possible to continue treatment with another fluoropyrimidine due to hand-foot syndrome or cardiovascular toxicity that developed in the adjuvant or metastatic setting.

Ontozry Európska únia - slovinčina - EMA (European Medicines Agency)

ontozry

angelini pharma s.p.a - cenobamate - epilepsija - antiepileptics, - adjunctive treatment of focal-onset seizures with or without secondary generalisation in adult patients with epilepsy who have not been adequately controlled despite a history of treatment with at least 2 anti-epileptic medicinal products.

Onureg Európska únia - slovinčina - EMA (European Medicines Agency)

onureg

bristol-myers squibb pharma eeig - azacitidin - leukemija, myeloid, akutna - antineoplastična sredstva - onureg is indicated as maintenance therapy in adult patients with acute myeloid leukaemia (aml) who achieved complete remission (cr) or complete remission with incomplete blood count recovery (cri) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (hsct).