União Europeia - esloveno - EMA (European Medicines Agency)

pfizer europe ma eeig - lorlatinib - karcinom, pljučni pljuč - antineoplastic agents, protein kinase inhibitors - lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (alk)‑positive advanced non‑small cell lung cancer (nsclc) previously not treated with an alk inhibitor. lorviqua as monotherapy is indicated for the treatment of adult patients with alk‑positive advanced nsclc whose disease has progressed after:alectinib or ceritinib as the first alk tyrosine kinase inhibitor (tki) therapy; orcrizotinib and at least one other alk tki.

União Europeia - esloveno - 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.

União Europeia - esloveno - EMA (European Medicines Agency)

janssen-cilag international n.v. - talquetamab - multiple myeloma - antineoplastična sredstva - talvey is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti cd38 antibody and have demonstrated disease progression on the last therapy.

União Europeia - esloveno - EMA (European Medicines Agency)

photonamic gmbh & co. kg - 5-aminolevulinična kislina hidroklorid - glioma - antineoplastična sredstva - gliolan je indiciran pri odraslih bolnikih za vizualizacijo malignih tkiv med operacijo malignih glioma (iii. in iv. svetovna zdravstvena organizacija).

União Europeia - esloveno - EMA (European Medicines Agency)

incyte biosciences distribution b.v. - ponatinib - leukemia, myeloid; leukemia, lymphoid - antineoplastic agents, protein kinase inhibitors - iclusig is indicated in adult patients withchronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (cml) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutationphiladelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutation. glej poglavja 4. 2 assessment of cardiovascular status prior to start of therapy and 4. 4 situations where an alternative treatment may be considered.

União Europeia - esloveno - EMA (European Medicines Agency)

teva b.v. - imatinib mesilate - dermatofibrosarcoma; gastrointestinal stromal tumors; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastična sredstva - imatinib teva b. is indicated for the treatment of: , paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. , pediatričnih bolnikih s ph+ cml v kronični fazi po izpadu interferon-alfa terapije, ali v pospešeni fazi ali pišu krize. odrasli bolniki s ph+ cml v blastni krizi. , odraslih in pediatričnih bolnikih, ki so na novo zboleli za philadelphia kromosom pozitivno acute lymphoblastic levkemijo (ph+ all), ki je integriran z kemoterapijo. odrasli bolniki z relapsed ali ognjevzdržni ph+ all, kot monotherapy. odrasli bolniki z myelodysplastic/myeloproliferative bolezni (mds/mpd), ki je povezana z trombocitov, pridobljenih iz rastni dejavnik receptorjev (pdgfr) gena ponovno ureditev. odrasli bolniki z napredno hypereosinophilic sindromom (hes) in/ali kronično eozinofilno levkemijo (cel) z fip1l1-pdgfra preureditev. učinek imatinib na izid presaditev kostnega mozga, ni bilo določeno. imatinib teva b. is indicated for: , the treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). , adjuvant zdravljenje odraslih bolnikov, ki so na veliko nevarnost ponovitve naslednje resekcija kit (cd117)-pozitivno bistvo. bolniki, ki imajo nizko ali zelo nizko tveganje za ponovitev, ne bi smel imeti adjuvant treatment. , zdravljenje odraslih bolnikov z unresectable dermatofibrosarcoma protuberans (dfsp) in odraslih bolnikih s ponavljajočimi in/ali metastatskim dfsp, ki niso primerni za operacijo. v izobraževanju odraslih in pediatričnih bolnikov, učinkovitost imatinib temelji na splošno hematoloških in postopek citogenetske stopnjo odziva in napredovanje-free survival v cml, na hematoloških in postopek citogenetske stopnjo odziva, v ph+ all, mds/mpd, na hematoloških stopnjo odziva, v hes/cel in na cilj stopnjo odziva pri odraslih bolnikih z unresectable in/ali metastatskim bistvo in dfsp in na ponovitev-free survival v adjuvant bistvo. izkušnje z imatinib pri bolnikih z mds/mpd, povezanih z pdgfr gena ponovno ureditev je zelo omejena. ni kontroliranih preskušanjih, dokazujejo kliničnih koristi ali poveča preživetje pri teh bolezni.

União Europeia - esloveno - EMA (European Medicines Agency)

nova laboratories ireland limited - hidroksikarbamid - anemija, srčna celica - antineoplastična sredstva - preprečevanje vaso-okluzivni zapletov anemija srpastih celic bolezni pri bolnikih nad 2 leti starosti.

União Europeia - esloveno - EMA (European Medicines Agency)

seagen b.v. - tucatinib - breast neoplasms; neoplasm metastasis - antineoplastična sredstva - tukysa is indicated in combination with trastuzumab and capecitabine for the treatment of adult patients with her2‑positive locally advanced or metastatic breast cancer who have received at least 2 prior anti‑her2 treatment regimens.

União Europeia - esloveno - 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.

União Europeia - esloveno - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - kapecitabin - kolorektalne neoplazme - antineoplastična sredstva - zdravilo capecitabine medac je indicirano za adjuvantno zdravljenje bolnikov po operaciji stopnje iii (dukes 'stage-c) debelega črevesa. capecitabine medac je primerna za zdravljenje metastatskega raka debelega črevesa in danke. capecitabine medac je določen za prvo linijo zdravljenja naprednih raka želodca v kombinaciji z platinum, ki temelji režim. capecitabine medac v kombinaciji z docetaxel je indiciran za zdravljenje bolnikov z lokalno napredno ali metastatskega raka dojke po okvari citotoksična kemoterapija. predhodno zdravljenje bi moralo vključiti antraciklin. capecitabine medac je prikazano tudi kot monotherapy za zdravljenje bolnikov z lokalno napredno ali metastatskega raka dojke po okvari taxanes in anthracycline-ki vsebujejo kemoterapijo režim ali za koga še anthracycline zdravljenje ni navedeno.