Europos Sąjunga - slovėnų - EMA (European Medicines Agency)

novartis europharm limited - tislelizumab - esophageal squamous cell carcinoma - antineoplastična sredstva - oesophageal squamous cell carcinoma (oscc) tevimbra as monotherapy is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma after prior platinum-based chemotherapy.

Europos Sąjunga - slovėnų - EMA (European Medicines Agency)

pfizer europe ma eeig  - voxelotor - anemia; anemia, hemolytic; anemia, sickle cell - other hematological agents - oxbryta is indicated for the treatment of haemolytic anaemia due to sickle cell disease (scd) in adults and paediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide.

Europos Sąjunga - slovėnų - EMA (European Medicines Agency)

astrazeneca ab - anifrolumab - lupus erythematosus, sistemski - imunosupresivi - saphnelo is indicated as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (sle), despite standard therapy.

Europos Sąjunga - slovėnų - EMA (European Medicines Agency)

novartis europharm limited  - capmatinib dihydrochloride monohydrate - karcinom, pljučni pljuč - antineoplastična sredstva - tabrecta as monotherapy is indicated for the treatment of adult patients with advanced non small cell lung cancer (nsclc) harbouring alterations leading to mesenchymal epithelial transition factor gene exon 14 (metex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum based chemotherapy.

Europos Sąjunga - slovėnų - 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.

Europos Sąjunga - slovėnų - 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.

Europos Sąjunga - slovėnų - EMA (European Medicines Agency)

pharmaand gmbh - rucaparib camsylate - ovarijske neoplazme - antineoplastična sredstva - rubraca is indicated as monotherapy for the maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. rubraca je označen kot monotherapy za vzdrževanje zdravljenje odraslih bolnikov s platino-občutljive relapsed visoko-kakovostni razred epitelnih jajčnikov, fallopian tube, ali primarni trebušno raka, ki so v odziv (popolna ali delna) platinum, ki temelji kemoterapijo.

Europos Sąjunga - slovėnų - EMA (European Medicines Agency)

janssen-cilag international n.v.    - amivantamab - karcinom, pljučni pljuč - antineoplastična sredstva - rybrevant as monotherapy is indicated for treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating epidermal growth factor receptor (egfr) exon 20 insertion mutations, after failure of platinum-based chemotherapy.

Europos Sąjunga - slovėnų - EMA (European Medicines Agency)

roche registration gmbh  - glofitamab - lymphoma, large b-cell, diffuse - antineoplastična sredstva - columvi as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large b cell lymphoma (dlbcl), after two or more lines of systemic therapy.

Europos Sąjunga - slovėnų - EMA (European Medicines Agency)

ucb pharma sa - certolizumab pegol - crohnova bolezen - imunosupresivi - cimzia, in combination with methotrexate (mtx), is indicated for the treatment of moderate to severe, active rheumatoid arthritis (ra) in adult patients when the response to disease-modifying antirheumatic drugs (dmard) including methotrexate, has been inadequate. cimzia lahko podana kot monotherapy v primeru nestrpnost do metotreksatom ali ko nadaljnje zdravljenje z metotreksatom ni primerno. cimzia has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function, when given in combination with methotrexate.