Euroopan unioni - sloveeni - EMA (European Medicines Agency)

sandoz pharmaceuticals d.d. - nelarabin - predkroglomerna limfoma t-celična limfoblastna levkemija - antineoplastična sredstva - nelarabine je indiciran za zdravljenje bolnikov z t-celic acute lymphoblastic levkemijo (t-all) in t-celic lymphoblastic limfom (t-lbl), katerih bolezen ni odgovorila, ali je relapsed po zdravljenju z vsaj dvema kemoterapijo regimens. due to the small patient populations in these disease settings, the information to support these indications is based on limited data.

Euroopan unioni - sloveeni - EMA (European Medicines Agency)

pfizer europe ma eeig - nonacog alfa - hemofilija b - antihemoragije - zdravljenje in profilaksa krvavitve pri bolnikih s hemofilijo b (prirojeno pomanjkanje faktorja ix).

Euroopan unioni - sloveeni - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - predkroglomerna limfoblastna levkemija limfoma - antineoplastična sredstva - blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options. blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.

Euroopan unioni - sloveeni - EMA (European Medicines Agency)

cheplapharm arzneimittel gmbh - pioglitazone, metformin hidroklorid - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - competact is indicated in the treatment of type 2 diabetes mellitus patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.

Euroopan unioni - sloveeni - EMA (European Medicines Agency)

pfizer europe ma eeig - bazedoksifen - osteoporoza, postmenopavz - spolni hormoni in zdravila genitalni sistem, - zdravilo conbriza je indicirano za zdravljenje postmenopavzalne osteoporoze pri ženskah pri povečanem tveganju zloma. dokazano je bilo znatno zmanjšanje incidence zlomov vretenc; učinkovitost zloma kolka ni bila ugotovljena. pri določanju izbiro conbriza ali drugih terapij, vključno z oestrogens, za posameznika postmenopausal ženska, bi bilo treba preučiti, simptomov menopavze, vplivi na maternice in dojk tkiv, in žilnega tveganja in koristi.

Euroopan unioni - sloveeni - EMA (European Medicines Agency)

merck sharp & dohme b.v. - daptomicin - gram-positive bacterial infections; bacteremia; soft tissue infections; endocarditis, bacterial - antibacterials za sistemsko uporabo, - cubicin je indiciran za zdravljenje naslednjih okužb. odraslih in pediatričnih (1 do 17 let) pri bolnikih z zapleteno kože in mehkega tkiva okužb (cssti). odraslih bolnikih z desno-sided (obojestransko), infektivnih endocarditis (rie) zaradi staphylococcus aureus. priporočljivo je, da je odločitev za uporabo daptomycin je treba upoštevati, da protibakterijsko dovzetnost organizma in je treba na podlagi strokovno svetovanje. odraslih in pediatričnih (1 do 17 let) pri bolnikih s staphylococcus aureus bacteraemia (sab). pri odraslih, uporabite v bacteraemia bi morala biti povezana z rie ali z cssti, medtem ko so pri pediatričnih bolnikih, uporabite v bacteraemia bi morala biti povezana z cssti. daptomycin je aktiven proti gram pozitivne bakterije le. v mešanih okužb, kjer je za gram negativne in/ali določene vrste anaerobnih bakterij, ki so osumljene, cubicin je treba co-daje z ustrezno protibakterijsko zastopnik (- i). upoštevati je treba uradne smernice za ustrezno uporabo protibakterijsko agenti.

Euroopan unioni - sloveeni - EMA (European Medicines Agency)

recordati rare diseases - brezvodni betain - homocistinurija - drugi zdravljene bolezni prebavil in presnove izdelki, - adjunctive treatment of homocystinuria, involving deficiencies or defects in:cystathionine beta-synthase (cbs);5,10-methylene-tetrahydrofolate reductase (mthfr);cobalamin cofactor metabolism (cbl). cystadane should be used as supplement to other therapies such as vitamin b6 (pyridoxine), vitamin b12 (cobalamin), folate and a specific diet.

Euroopan unioni - sloveeni - EMA (European Medicines Agency)

novartis europharm ltd. - aliskiren - hipertenzija - sredstva, ki delujejo na sistem renin-angiotenzin - zdravljenje esencialne hipertenzije.

Euroopan unioni - sloveeni - EMA (European Medicines Agency)

omrix biopharmaceuticals n. v. - humani fibrinogen, humani trombin - hemostaza - lokalni hemostatics - podporno zdravljenje pri operaciji odraslih, pri katerem so standardne kirurške tehnike nezadostne (glejte poglavje 5). 1):- za izboljšanje haemostasis.

Euroopan unioni - sloveeni - EMA (European Medicines Agency)

novartis europharm limited - imatinib - precursor cell lymphoblastic leukemia-lymphoma; gastrointestinal stromal tumors; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - antineoplastična sredstva - glivec is indicated for the treatment of , adult and 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;, adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult and paediatric patients with newly diagnosed philadelphia-chromosome-positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy;, adult patients with relapsed or refractory ph+ all as monotherapy;, adult patients with myelodysplastic / myeloproliferative diseases (mds / mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements;, adult patients with advanced hypereosinophilic syndrome (hes) and / or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfra rearrangement. učinek glivec na izid kostnega mozga presaditev ni bilo določeno. glivec is indicated for: , the treatment of adult patients with kit (cd 117)-positive unresectable and / or metastatic malignant gastrointestinal stromal tumours (gist);, the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. 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 glivec je na podlagi 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 glivec pri bolnikih z mds / mpd, povezanih z pdgfr gena ponovno ureditev je zelo omejeno (glej poglavje 5. razen v novo diagnozo kronične faze cml, ni kontroliranih preskušanjih, dokazujejo kliničnih koristi ali poveča preživetje pri teh bolezni.