Union européenne - slovène - EMA (European Medicines Agency)

eli lilly nederland b.v. - tirzepatide - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - mounjaro is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise- as monotherapy when metformin is considered inappropriate due to intolerance or contraindications- in addition to other medicinal products for the treatment of diabetes. for study results with respect to combinations, effects on glycaemic control and the populations studied, see sections 4. 4, 4. 5 in 5.

Union européenne - slovène - EMA (European Medicines Agency)

gilead sciences ireland uc - idelalisib - lymphoma, non-hodgkin; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, other antineoplastic agents - zydelig is indicated in combination with an anti‑cd20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (cll):who have received at least one prior therapy, oras first line treatment in the presence of 17p deletion or tp53 mutation in patients who are not eligible for any other therapies. zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (fl) that is refractory to two prior lines of treatment.

Union européenne - slovène - EMA (European Medicines Agency)

swedish orphan biovitrum ab - loncastuximab tesirine - lymphoma, large b-cell, diffuse; lymphoma, b-cell - antineoplastična sredstva - zynlonta as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) and high-grade b-cell lymphoma (hgbl), after two or more lines of systemic therapy.

Union européenne - slovène - EMA (European Medicines Agency)

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.

Union européenne - slovène - EMA (European Medicines Agency)

mylan pharmaceuticals limited - memantinijev klorid - alzheimerjeva bolezen - other anti-dementia drugs, psychoanaleptics, - zdravljenje bolnikov z zmerno do hudo alzheimerjevo boleznijo.

Union européenne - slovène - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - lanadelumab - angioedem, dedno - other hematological agents - takhzyro is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae) in patients aged 2 years and older.

Union européenne - slovène - EMA (European Medicines Agency)

novartis europharm limited  - voretigene neparvovec - leber congenital amaurosis; retinitis pigmentosa - other ophthalmologicals - luxturna je indiciran za zdravljenje odraslih in pediatričnih bolnikih z izgubo vida zaradi dedne očesne mrežnice distrofija, ki jih povzročajo potrdili biallelic rpe65 mutacije in ki imajo dovolj preživetja celic mrežnice.

Union européenne - slovène - EMA (European Medicines Agency)

bluebird bio (netherlands) b.v. - autologous cd34+ celic, obogaten prebivalstva, ki vsebuje hematopoietic izvornih celic transduced z lentiglobin bb305 lentiviral vektor kodiranje beta-a-t87q-globin gena - beta-talasemija - other hematological agents - zynteglo je indiciran za zdravljenje bolnikov, 12 let in več, s transfuzijo, ki je odvisna β talasemija (tdt), ki nimajo β0/β0 genotip, za katere haematopoietic stem cell (hsc) presaditev, je primerno, ampak človeško leukocyte antigen (hla) ujema povezane hsc donatorjev ni na voljo.

Union européenne - slovène - EMA (European Medicines Agency)

alfasigma s.p.a. - metiltioninijev klorid - colorectal neoplasms; colonoscopy - other diagnostic agents - lumeblue is indicated as a diagnostic agent enhancing visualisation of colorectal lesions in adult patients undergoing screening or surveillance colonoscopy.

Union européenne - slovène - EMA (European Medicines Agency)

biocryst ireland limited - berotralstat dihydrochloride - angioedem, dedno - other hematological agents - orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae) in adult and adolescent patients aged 12 years and older.