Euroopan unioni - suomi - EMA (European Medicines Agency)

betapharm arzneimittel gmbh - atsakitidiini - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastiset aineet - atsasitidiini betapharm on tarkoitettu aikuispotilaille, jotka eivät ole oikeutettuja hematopoieettiset kantasolusiirto (hsct) kanssa:intermediate-2 ja korkean riskin myelodysplastinen oireyhtymä (mds) mukaan international prognostic scoring system (ipss),krooninen myelomonocytic leukemia (cmml) 10 % 29 % luuytimen räjäytykset ilman myeloproliferative häiriö,akuutti myelooinen leukemia (aml), jossa on 20 % 30 % blasteja ja multi-lineage dysplasia, mukaan maailman terveysjärjestön (who) luokitukseen,aml > 30 % luuytimessä blasteja who: n luokitus.

Euroopan unioni - suomi - EMA (European Medicines Agency)

accord healthcare s.l.u. - atsakitidiini - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastiset aineet - atsasitidiini accord on tarkoitettu aikuispotilaille, jotka eivät ole oikeutettuja hematopoieettiset kantasolusiirto (hsct) kanssa:- intermediate-2 ja korkean riskin myelodysplastinen oireyhtymä (mds) mukaan international prognostic scoring system (ipss),- krooninen myelomonocytic leukemia (cmml), jossa on 10-29 % luuytimen räjäytykset ilman myeloproliferative häiriö,- akuutti myelooinen leukemia (aml), jossa 20-30 % blasteja ja multi-lineage dysplasia, mukaan maailman terveysjärjestön (who) luokittelu,- aml - >30% luuytimessä blasteja who: n luokitus.

Euroopan unioni - suomi - EMA (European Medicines Agency)

adienne s.r.l. s.u. - melphalan hydrochloride - multiple myeloma; hodgkin disease; lymphoma, non-hodgkin; precursor cell lymphoblastic leukemia-lymphoma; leukemia, myeloid, acute; neuroblastoma; ovarian neoplasms; hematopoietic stem cell transplantation - antineoplastiset aineet - high-dose of phelinun used alone or in combination with other cytotoxic medicinal products and/or total body irradiation is indicated in the treatment of:multiple myeloma,malignant lymphoma (hodgkin, non-hodgkin lymphoma),acute lymphoblastic and myeloblastic leukemia,childhood neuroblastoma,ovarian cancer,mammary adenocarcinoma. phelinun in combination with other cytotoxic medicinal products is indicated as reduced intensity conditioning (ric) treatment prior to allogeneic haematopoietic stem cell transplantation (allo-hsct) in malignant haematological diseases in adults. phelinun in combination with other cytotoxic medicinal products is indicated as conditioning regimen prior to allogeneic haematopoietic stem cell transplantation in haematological diseases in the paediatric population as:myeloablative conditioning (mac) treatment in case of malignant haematological diseasesric treatment in case of non-malignant haematological diseases.

Euroopan unioni - suomi - EMA (European Medicines Agency)

laboratoires delbert - histamiini - leukemia, myeloidi, akuutti - immunostimulantit, - ceplene maintenance therapy is indicated for adult patients with acute myeloid leukaemia in first remission concomitantly treated with interleukin-2 (il-2). ceplenin tehokkuutta ei ole täysin osoitettu yli 60-vuotiailla potilailla.

Euroopan unioni - suomi - EMA (European Medicines Agency)

janssen-cilag international n.v.   - decitabine - leukemia, myeloidi - antineoplastiset aineet - uusien diagnosoitujen de novo tai toissijainen akuutti myelooinen leukemia (aml) maailman terveysjärjestön (who)-luokituksen mukaisesti aikuisten potilaille, jotka eivät ole ehdolla standardin induktio solunsalpaajahoitoa.

Euroopan unioni - suomi - 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. katso kohdat 4. 2 assessment of cardiovascular status prior to start of therapy and 4. 4 situations where an alternative treatment may be considered.

Euroopan unioni - suomi - EMA (European Medicines Agency)

actavis group ptc ehf - imatinibi - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - protein kinase inhibitors, antineoplastic agents - imatinib actavis 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;, paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult patients with ph+ cml in blast crisis;, adult 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-pdgfr rearrangement;, 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. vaikutukset imatinibi on luuytimensiirron lopputulokseen ei ole selvitetty. imatinib actavis is indicated for: , 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 dfsp. kokemusta imatinib potilailla, joilla on mds/mpd, jotka liittyvät pdgfr-geenin uudelleenjärjestäytymisen yhteydessä järjestelyt on hyvin rajallinen. ei ole kontrolloituja tutkimuksia, jotka osoittaisivat kliinistä tehoa tai eloonjäämisetua näissä sairauksia.

Euroopan unioni - suomi - EMA (European Medicines Agency)

lipomed gmbh - kladribiini - leukemia, karvainen solu - antineoplastiset aineet - litak on tarkoitettu karvasoluleukemian hoitoon.

Euroopan unioni - suomi - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - venetoclax - leukemia, lymfosyyttinen, krooninen, b-solu - antineoplastiset aineet - venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. venclyxto in combination with rituximab is indicated for the treatment of adult patients with cll who have received at least one prior therapy. venclyxto monotherapy is indicated for the treatment of cll:- in the presence of 17p deletion or tp53 mutation in adult patients who are unsuitable for or have failed a b cell receptor pathway inhibitor, or- in the absence of 17p deletion or tp53 mutation in adult patients who have failed both chemoimmunotherapy and a b-cell receptor pathway inhibitor. venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly  diagnosed acute myeloid leukaemia (aml) who are ineligible for intensive chemotherapy.

Euroopan unioni - suomi - EMA (European Medicines Agency)

pfizer europe ma eeig - glasdegib maleate - leukemia, myeloidi, akuutti - antineoplastiset aineet - daurismo is indicated, in combination with low-dose cytarabine, for the treatment of newly diagnosed de novo or secondary acute myeloid leukaemia (aml) in adult patients who are not candidates for standard induction chemotherapy.