Uniunea Europeană - română - EMA (European Medicines Agency)

koanaa healthcare gmbh - imatinib mesilat - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - agenți antineoplazici - 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. pacienții care au un risc scăzut sau foarte scăzut de recidivă nu trebuie să primească tratament adjuvant. 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. cu excepția nou diagnosticate în faza cronică a lgc, nu există studii controlate care să demonstreze un beneficiu clinic sau a crescut de supraviețuire pentru aceste boli.

România - română - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

as grindeks - letonia - imatinibum - caps. - 100mg - inhibitori de protein-kinaza

România - română - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

novartis pharma gmbh - germania - imatinibum - caps. - 100mg - inhibitori de protein-kinaza

România - română - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

accord healthcare polska sp.z o.o. - polonia - imatinibum - compr. film. - 100mg - inhibitori de protein-kinaza

România - română - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

accord healthcare polska sp.z o.o. - polonia - imatinibum - compr. film. - 400mg - inhibitori de protein-kinaza

România - română - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

teva czech industries s.r.o. - republica ceha - imatinibum - compr. film. - 100mg - inhibitori de protein-kinaza

România - română - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

teva czech industries s.r.o. - republica ceha - imatinibum - compr. film. - 400 mg - inhibitori de protein-kinaza