Europese Unie - Sloveens - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - elotuzumab - multiple myeloma - antineoplastična sredstva - empliciti je navedeno v kombinaciji z lenalidomide in dexamethasone za zdravljenje več plazmocitom pri odraslih bolnikih, ki so prejeli vsaj eno predhodno zdravljenje (glej točki 4. 2 in 5.

Europese Unie - Sloveens - 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.

Europese Unie - Sloveens - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - lenalidomid - multiple myeloma; lymphoma, mantle-cell; myelodysplastic syndromes - imunosupresivi - več myelomarevlimid kot monotherapy je označen za vzdrževanje zdravljenje odraslih bolnikov z na novo prijavljenih več plazmocitom, ki so bili autologous presaditev matičnih celic. revlimid kot kombinacija terapije z dexamethasone, ali bortezomib in dexamethasone, ali melphalan in prednizon (glej poglavje 4. 2) je indiciran za zdravljenje odraslih bolnikov s predhodno nezdravljenih več plazmocitom, ki niso primerni za presaditev. revlimid v kombinaciji z dexamethasone je primerna za zdravljenje več plazmocitom pri odraslih bolnikih, ki so prejeli vsaj en pred terapijo. myelodysplastic syndromesrevlimid kot monotherapy je indiciran za zdravljenje odraslih bolnikov s transfuzijo-odvisne anemije zaradi nizko - ali vmesne-1-tveganje myelodysplastic sindromov, povezanih z osamljen izbris 5q postopek citogenetske nepravilnosti pri drugih terapevtskih možnosti so nezadostna ali neustrezna. plašč celice lymphomarevlimid kot monotherapy je indiciran za zdravljenje odraslih bolnikov z relapsed ali ognjevzdržni plašč limfom celic. folikularni lymphomarevlimid v kombinaciji z rituksimabom (anti-cd20 protiteles) je indiciran za zdravljenje odraslih bolnikov s predhodno zdravljenih folikularni limfom (razred 1 – 3a).

Europese Unie - Sloveens - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - thalidomide - multiple myeloma - imunosupresivi - thalidomide bms in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged >/= 65 years or ineligible for high dose chemotherapy. thalidomide bms is prescribed and dispensed according to the thalidomide celgene pregnancy prevention programme (see section 4.

Europese Unie - Sloveens - EMA (European Medicines Agency)

recordati netherlands b.v. - siltuximab - hyperplazija ogromne limfne vozle - imunosupresivi - zdravilo silent je indicirano za zdravljenje odraslih bolnikov z multicentrično castlemanovo boleznijo (mcd, ki so negativni virus hiv in humani herpesvirus-8 (hhv-8) negativni.

Europese Unie - Sloveens - EMA (European Medicines Agency)

mylan ireland limited - lenalidomid - multiple myeloma - imunosupresivi - multiple myelomalenalidomide mylan as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide mylan as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. lenalidomide mylan in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. follicular lymphomalenalidomide mylan in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1-3a).

Slovenië - Sloveens - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

adamed sp. z.o.o - imatinib - kapsula, trda - imatinib 100 mg / 1 kapsula - imatinib

Slovenië - Sloveens - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

adamed sp. z.o.o - imatinib - kapsula, trda - imatinib 100 mg / 1 kapsula - imatinib

Slovenië - Sloveens - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

adamed sp. z.o.o - imatinib - kapsula, trda - imatinib 100 mg / 1 kapsula - imatinib

Slovenië - Sloveens - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

adamed sp. z.o.o - imatinib - kapsula, trda - imatinib 100 mg / 1 kapsula - imatinib