Európai Unió - szlovén - EMA (European Medicines Agency)

gilead sciences ireland uc - sofosbuvir, velpatasvir, voxilaprevi - hepatitis c, kronični - antivirusi za sistemsko uporabo - vosevi is indicated for the treatment of chronic hepatitis c virus (hcv) infection in patients aged 12 years and older and weighing at least 30 kg. (glej točki 4. 2, 4. 4 in 5.

Európai Unió - szlovén - EMA (European Medicines Agency)

orphelia pharma sas - vigabatrin - spasms, infantile; epilepsies, partial - antiepileptics, - kigabeq je navedeno pri dojenčkih in otrocih od 1 meseca do manj kot 7 leta starosti za:zdravljenje v monotherapy infantilne krči (west sindrom). zdravljenje v kombinaciji z drugimi antiepileptiki zdravil pri bolnikih z odporno delno epilepsijo (osrednja nastop zasegov) z ali brez sekundarne posplošitev, da je, če vse drugo ustrezno zdravilo kombinacije so se izkazali kot neprimerni ali niso bili prenaša.

Európai Unió - szlovén - EMA (European Medicines Agency)

kite pharma eu b.v. - axicabtagene ciloleucel - lymphoma, follicular; lymphoma, large b-cell, diffuse - antineoplastična sredstva - yescarta is indicated for the treatment of adult patients with diffuse large b cell lymphoma (dlbcl) and high-grade b-cell lymphoma (hgbl) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy. yescarta is indicated for the treatment of adult patients with relapsed or refractory (r/r) dlbcl and primary mediastinal large b cell lymphoma (pmbcl), after two or more lines of systemic therapy. yescarta is indicated for the treatment of adult patients with r/r follicular lymphoma (fl) after three or more lines of systemic therapy.

Szlovénia - szlovén - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

intervet international -

Európai Unió - szlovén - EMA (European Medicines Agency)

celgene europe bv - azacitidin - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastična sredstva - azacitidine celgene is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (hsct) with:intermediate 2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss),chronic myelomonocytic leukaemia (cmml) with 10 29 % marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (aml) with 20 30 % blasts and multi-lineage dysplasia, according to world health organisation (who) classification,aml with >30% marrow blasts according to the who classification.

Európai Unió - szlovén - EMA (European Medicines Agency)

novartis europharm limited  - siponimod fumaric acid - multiplo sklerozo, recidivno-nakazila - selektivni imunosupresivi - mayzent je indiciran za zdravljenje odraslih bolnikov s sekundarno progresivno multiplo sklerozo (spms), ki imajo aktivno bolezen, dokazuje zagonov ali slikovne funkcije vnetne aktivnosti.

Európai Unió - szlovén - EMA (European Medicines Agency)

accord healthcare s.l.u. - dexmedetomidine - premedication - psiholeptiki - za sedacijo odraslih icu (enoti za intenzivno nego) bolnikov, ki potrebujejo sedacijo ravni ne globlje, kot je vzburjenje v odgovor na verbalne dražljaje (ustrezno richmond vznemirjenost-sedacija lestvici (rass) 0 -3). za sedacijo non-intubated odraslih bolnikov pred in/ali v diagnostične ali kirurški postopki, ki zahtevajo sedacijo, i. postopkovna/buden sedacijo.

Európai Unió - szlovén - EMA (European Medicines Agency)

novartis europharm limited  - alpelisib - neoplazme dojke - antineoplastična sredstva - piqray je navedeno v kombinaciji z fulvestrant za zdravljenje pri ženskah po menopavzi, in moški, hormonski receptor (hr)-pozitiven, human epidermalna rast factor receptor 2 (her2)-negativna, lokalno napredno ali metastatskega raka dojke z pik3ca mutacije po napredovanja bolezni naslednje endokrine terapije kot monotherapy (glej poglavje 5.

Európai Unió - szlovén - EMA (European Medicines Agency)

orchard therapeutics (netherlands) bv - atidarsagene autotemcel - leukodystrophy, metachromatic - druga zdravila na živčnem sistemu - libmeldy is indicated for the treatment of metachromatic leukodystrophy (mld) characterized by biallelic mutations in the arysulfatase a (arsa) gene leading to a reduction of the arsa enzymatic activity:in children with late infantile or early juvenile forms, without clinical manifestations of the disease,in children with the early juvenile form, with early clinical manifestations of the disease, who still  have the ability to walk independently and before the onset of cognitive decline.

Európai Unió - szlovén - EMA (European Medicines Agency)

stemline therapeutics b.v. - selinexor - multiple myeloma - antineoplastična sredstva - nexpovio is indicatedin combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-cd38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.