Európai Unió - magyar - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - az arzén-trioxid - leukémia, promyelocytic, akut - daganatellenes szerek - arsenic trioxide medac is indicated for induction of remission, and consolidation in adult patients with:newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (apl) (white blood cell count, ≤ 10 x 10³/μl) in combination with all-trans-retinoic acid (atra)relapsed/refractory apl (previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the pro-myelocytic leukaemia/retinoic-acid-receptor-alpha (pml/rarα) gene. a válaszadási arány a más akut myeloid leukémia altípusa, hogy az arzén-trioxid nem vizsgálták.

Európai Unió - magyar - EMA (European Medicines Agency)

astrazeneca ab - acalabrutinib - leukémia, limfocitikus, krónikus, b-sejt - antineoplastic agents, protein kinase inhibitors, - calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll). calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (cll) who have received at least one prior therapy.

Európai Unió - magyar - EMA (European Medicines Agency)

astrazeneca ab - moxetumomab pasudotox - leukémia, szőrös sejt - daganatellenes szerek - lumoxiti as monotherapy is indicated for the treatment of adult patients with relapsed or refractory hairy cell leukaemia (hcl) after receiving at least two prior systemic therapies, including treatment with a purine nucleoside analogue (pna).

Európai Unió - magyar - EMA (European Medicines Agency)

secura bio limited - duvelisib - leukemia, lymphocytic, chronic, b-cell; lymphoma, follicular - daganatellenes szerek - copiktra monotherapy is indicated for the treatment of adult patients with: relapsed or refractory chronic lymphocytic leukaemia (cll) after at least two prior therapies.  follicular lymphoma (fl) that is refractory to at least two prior  systemic therapies.

Európai Unió - magyar - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - azacitidinnel - leukémia, mieloid, akut - daganatellenes szerek - onureg is indicated as maintenance therapy in adult patients with acute myeloid leukaemia (aml) who achieved complete remission (cr) or complete remission with incomplete blood count recovery (cri) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (hsct).

Európai Unió - magyar - EMA (European Medicines Agency)

koanaa healthcare gmbh - imatinib mesilate - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - daganatellenes szerek - imatinib koanaa is indicated for the treatment ofadult 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-pdgfrα rearrangement. the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib koanaa is indicated forthe 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. azok a betegek, akik alacsony, vagy nagyon alacsony kiújulás kockázata nem kaphat adjuváns kezelés. the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. kivéve, hogy az újonnan diagnosztizált, krónikus fázisú cml-nincs kontrollált vizsgálatok, amelyek klinikai haszon vagy fokozott túlélés ezek a betegségek.

Európai Unió - magyar - EMA (European Medicines Agency)

novartis europharm limited - asciminib hydrochloride - leukémia, mielogén, krónikus, bcr-abl pozitív - daganatellenes szerek - scemblix is indicated for the treatment of adult patients with philadelphia chromosome positive chronic myeloid leukaemia in chronic phase (ph+ cml cp) previously treated with two or more tyrosine kinase inhibitors (see section 5.

Európai Unió - magyar - EMA (European Medicines Agency)

les laboratoires servier - ivosidenib - leukemia, myeloid, acute; cholangiocarcinoma - daganatellenes szerek - tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (aml) with an isocitrate dehydrogenase-1 (idh1) r132 mutation who are not eligible to receive standard induction chemotherapy (see section 5. tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an idh1 r132 mutation who were previously treated by at least one prior line of systemic therapy.

Európai Unió - magyar - EMA (European Medicines Agency)

sandoz pharmaceuticals d.d. - nelarabin - prekurzor t-sejt limfoblasztikus leukémia-limfóma - daganatellenes szerek - nelarabin kezelésére javallt, a betegek, a t-sejt akut limfoblasztos leukémia (t -) t-sejt limfoblasztos lymphoma (t-lbl), akiknek a betegség már nem válaszolt, vagy kiújult kezelést követően legalább két kemoterápiás kezelések. due to the small patient populations in these disease settings, the information to support these indications is based on limited data.

Európai Unió - magyar - EMA (European Medicines Agency)

sanofi b.v. - klofarabint - prekurzorsejt limfoblasztikus leukémia-limfóma - daganatellenes szerek - kezelése akut limfoblasztos leukémia (all) a gyermekgyógyászati betegeknél, akik már visszaesett, illetve tűzálló után legalább két előzetes kezelésben részesülő és amennyiben nincs más kezelési lehetőség várható eredmény-ban egy tartós válasz. a biztonságossági és hatásossági tényezőket a kezdeti diagnózis esetén a 21 évnél fiatalabb betegeknél vizsgálták.