Európai Unió - szlovén - EMA (European Medicines Agency)

novartis europharm limited - everolimus - tuberozna skleroza - antineoplastična sredstva - ledvična angiomyolipoma, povezanih z tuberous sklerozo kompleks (tsc)votubia je indiciran za zdravljenje odraslih bolnikov z ledvično angiomyolipoma, povezanih z tuberous sklerozo kompleks (tsc), ki so na tveganja za nastanek zapletov (ki temelji na dejavnikih, kot je velikost tumorja, prisotnost aneurysm, prisotnost ali več ali dvostranskih tumorji), ampak ki ne zahtevajo takojšnjo operacijo. dokazi, ki temeljijo na analizi sprememb v vsoto angiomyolipoma glasnosti. subependymal velikan celice astrocitoma (sega), ki je povezana z tuberous sklerozo kompleks (tsc)votubia je indiciran za zdravljenje bolnikov z subependymal velikan celice astrocitoma (sega), ki je povezana z tuberous sklerozo kompleks (tsc), ki zahtevajo terapevtski poseg, vendar niso podvržene operacijo. dokazi, ki temeljijo na analizi sprememb v sega glasnosti. nadaljnje klinične koristi, kot so izboljšanje bolezni, povezane simptome, ni bilo dokazano,.

Európai Unió - szlovén - EMA (European Medicines Agency)

amgen europe b.v. - adalimumab - arthritis, psoriatic; spondylitis, ankylosing; crohn disease; colitis, ulcerative; hidradenitis suppurativa; psoriasis; arthritis, rheumatoid - imunosupresivi - glejte poglavje 4. 1 povzetka glavnih značilnosti zdravila v dokumentu z informacijami o izdelku.

Európai Unió - szlovén - EMA (European Medicines Agency)

eli lilly nederland b.v. - drotrekogin alfa (aktiviran) - sepsis; multiple organ failure - antitrombotična sredstva - zdravilo xigris je indicirano za zdravljenje odraslih bolnikov s hudo sepso z večkratnim odpovedovanjem organov, kadar so dodani najboljši standardni oskrbi. uporaba zdravila xigris je treba obravnavati predvsem v primerih, ko se zdravljenje lahko začne 24 ur po začetku odpovedi organa (za nadaljnje informacije glejte poglavje 5.

Európai Unió - szlovén - EMA (European Medicines Agency)

kyowa kirin holdings b.v. - burosumab - hypophosphatemia, familial; hypophosphatemic rickets, x-linked dominant; osteomalacia - zdravila za zdravljenje bolezni kosti - crysvita is indicated for the treatment of x-linked hypophosphataemia, in children and adolescents aged 1 to 17 years with radiographic evidence of bone disease, and in adults. crysvita is indicated for the treatment of fgf23-related hypophosphataemia in tumour-induced osteomalacia associated with phosphaturic mesenchymal tumours that cannot be curatively resected or localised in children and adolescents aged 1 to 17 years and in adults.

Európai Unió - szlovén - EMA (European Medicines Agency)

pierre fabre medicament - encorafenib - melanoma; colorectal neoplasms - antineoplastična sredstva - encorafenib is indicated:in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutationin combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (crc) with a braf v600e mutation, who have received prior systemic therapy.

Európai Unió - szlovén - EMA (European Medicines Agency)

pierre fabre medicament - binimetinib - melanoma - antineoplastična sredstva - binimetinib v kombinaciji z encorafenib je indiciran za zdravljenje odraslih bolnikov z unresectable ali metastatskega melanoma z braf v600 mutacija.

Európai Unió - szlovén - EMA (European Medicines Agency)

mylan pharmaceuticals limited - gefitinib - karcinom, pljučni pljuč - antineoplastic agents, protein kinase inhibitors - gefitinib mylan je označen kot monotherapy za zdravljenje odraslih bolnikov z lokalno napredno ali metastatskim non‑small cell lung cancer (nsclc) z aktiviranjem mutacije z egfr‑tk.

Európai Unió - szlovén - EMA (European Medicines Agency)

novartis europharm limited - tisagenlecleucel - precursor b-cell lymphoblastic leukemia-lymphoma; lymphoma, large b-cell, diffuse - drugi antineoplastiki - kymriah is indicated for the treatment of:• paediatric and young adult patients up to and including 25 years of age with b cell acute lymphoblastic leukaemia (all) that is refractory, in relapse post transplant or in second or later relapse. • adult patients with relapsed or refractory diffuse large b cell lymphoma (dlbcl) after two or more lines of systemic therapy. • adult patients with relapsed or refractory follicular lymphoma (fl) after two or more lines of systemic therapy.

Európai Unió - szlovén - EMA (European Medicines Agency)

ratiopharm gmbh - paklitaksel - neoplazme dojke - antineoplastična sredstva - pazenir monotherapy je primerna za zdravljenje metastatskega raka dojk pri odraslih bolnikih, ki niso uspeli prvo linijo zdravljenja metastatskega bolezni in za koga standard, anthracycline, ki vsebujejo zdravljenje ni navedeno. pazenir v kombinaciji z carboplatin je določen za prvo linijo zdravljenja non-small cell lung cancer pri odraslih bolnikih, ki niso kandidati za potencialno kurativno operacijo in/ali obsevanjem.

Európai Unió - szlovén - EMA (European Medicines Agency)

sanofi winthrop industrie - isatuximab - multiple myeloma - antineoplastična sredstva - sarclisa is indicated: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma (mm) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (pi) and have demonstrated disease progression on the last therapy. in combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (see section 5.