Unione Europea - italiano - EMA (European Medicines Agency)

ab science s.a. - masitinib mesilate - agenti antineoplastici - cani - trattamento di tumori mastocellulari del cane non resecabili (grado 2 o 3) con recettore tirosin-chinasi modificato c-kit mutato.

Unione Europea - italiano - EMA (European Medicines Agency)

ab science - masitinib mesilate - mastocitosi - agenti antineoplastici - trattamento di mastocitosi.

Unione Europea - italiano - EMA (European Medicines Agency)

ab science - masitinib mesilate - sclerosi laterale amiotrofica - agenti antineoplastici - trattamento della sclerosi laterale amiotrofica.

Unione Europea - italiano - EMA (European Medicines Agency)

ab science - masitinib - neoplasie pancreatiche - inibitori della proteina chinasi - trattamento di non resecabile localmente avanzato o metastatico cancro del pancreas.

Unione Europea - italiano - EMA (European Medicines Agency)

masitinib - tumori stromali gastrointestinali - inibitori della proteina chinasi - trattamento di operabili e/o metastatici, tumori stromali del tratto gastrointestinale (gist).

Unione Europea - italiano - EMA (European Medicines Agency)

accord healthcare s.l.u. - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinib - imatinib accord 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-pdgfrα rearrangement. - adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. - 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. patients who have a low or very low risk of recurrence should not receive adjuvant treatmentthe effect of imatinib on the outcome of bone marrow transplantation has not been determined. 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. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. tranne che nel recente diagnosi di lmc in fase cronica, non ci sono studi clinici controllati che dimostrano un beneficio clinico o un aumento della sopravvivenza per queste malattie. .

Unione Europea - italiano - EMA (European Medicines Agency)

teva b.v. - imatinib mesilato - dermatofibrosarcoma; gastrointestinal stromal tumors; leukemia, myelogenous, chronic, bcr-abl positive - agenti antineoplastici - 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. , pazienti pediatrici con lmc ph+ in fase cronica dopo il fallimento della terapia con interferone-alfa, o in fase accelerata o in crisi blastica. , pazienti adulti con lmc ph+ in crisi blastica. adulti e pediatrici, pazienti con recente diagnosi di cromosoma philadelphia positivo da leucemia linfoblastica acuta (lla ph+) integrato con chemioterapia. adulti pazienti con recidiva o refrattaria ph+ in monoterapia. , pazienti adulti con malattie mielodisplastiche/mieloproliferative (mds/mpd) associati con platelet-derived growth factor receptor (pdgfr) gene ri-arrangiamenti. , pazienti adulti con sindrome ipereosinofila avanzata (hes) e/o con leucemia eosinofila cronica (cel) con riarrangiamento fip1l1-pdgfra riarrangiamento. l'effetto di imatinib sull'esito del trapianto di midollo osseo non è stata determinata. 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). il trattamento adiuvante di pazienti adulti ad alto rischio di recidiva dopo resezione del kit (cd117) gist positivi. i pazienti che hanno un basso o bassissimo rischio di recidiva non dovrebbero ricevere il trattamento adiuvante. il trattamento dei pazienti adulti con metastasi dermatofibrosarcoma protuberans (dfsp) e in pazienti adulti con recidivante e/o metastatico dfsp che non sono eleggibili per la chirurgia. in pazienti adulti e pediatrici, l'efficacia di imatinib è basato sulla complessiva ematologica e citogenetica tassi di risposta e di sopravvivenza libera da progressione in cml, ematologica e citogenetica tassi di risposta ph+, mds/mpd, su valori di risposta ematologica in hes/lec e su tassi di risposta obiettiva in pazienti adulti con operabili e/o metastatici gist e dfsp e la sopravvivenza libera da recidiva in adiuvante gist. l'esperienza con imatinib in pazienti con mds/mpd associate a riarrangiamenti del gene pdgfr è molto limitata. non ci sono studi clinici controllati che dimostrano un beneficio clinico o un aumento della sopravvivenza per queste malattie.

Unione Europea - italiano - EMA (European Medicines Agency)

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - agenti antineoplastici - dasatinib accord is indicated for the treatment of adult patients with:• ph+ acute lymphoblastic leukaemia (all) with resistance or intolerance to prior therapy. dasatinib accord is indicated for the treatment of paediatric patients with:• newly diagnosed ph+ all in combination with chemotherapy.

Unione Europea - italiano - EMA (European Medicines Agency)

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - agenti antineoplastici - dasatinib accordpharma is indicated for the treatment of adult patients with: newly diagnosed philadelphia chromosome positive (ph+) chronic myelogenous leukaemia (cml) in the chronic phase.  chronic, accelerated or blast phase cml with resistance or intolerance to prior therapy including imatinib.  ph+ acute lymphoblastic leukaemia (all) and lymphoid blast cml with resistance or intolerance to prior therapy. dasatinib accordpharma is indicated for the treatment of paediatric patients with: newly diagnosed ph+ cml in chronic phase (ph+ cml-cp) or ph+ cml-cp resistant or intolerant to prior therapy including imatinib.  newly diagnosed ph+ all in combination with chemotherapy.

Unione Europea - italiano - EMA (European Medicines Agency)

koanaa healthcare gmbh - imatinib mesilato - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - agenti antineoplastici - 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. i pazienti che hanno un basso o bassissimo rischio di recidiva non dovrebbero ricevere il trattamento adiuvante. 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. tranne che nel recente diagnosi di lmc in fase cronica, non ci sono studi clinici controllati che dimostrano un beneficio clinico o un aumento della sopravvivenza per queste malattie.