Izrael - engleski - Ministry of Health

trima israel pharmaceutical products maabarot ltd - imatinib as mesylate - film coated tablets - imatinib as mesylate 100 mg - imatinib - imatinib - trima is indicated for the• treatment of adult patients and children 3 years of age and above with ph+ chronic myeloid leukaemia (ph+ -cml) in chronic phase, accelerated phase or blast crisis.• treatment of adult patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). • adjuvant treatment of adult patients following complete gross resection of kit (cd117) positive gist.• treatment of adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukemia (ph+ all) integrated with chemotherapy. • treatment of adult patients with relapsed or refractory ph+ all as monotherapy. • treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery.• treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with pdgfr (platelet-derived growth factor receptor) gene re-arrangements. • treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) who have the fip1l1-pdgfrα fusion kinase (mutational analysis or fish demonstration of chic2 allele deletion) and for patients with hes and/or cel who are fip1l1- pdgfrα fusion kinase negative. • treatment of adult patients with aggressive systemic mastocytosis (asm) without the d816v c-kit mutation.

Izrael - engleski - Ministry of Health

trima israel pharmaceutical products maabarot ltd - imatinib as mesylate - film coated tablets - imatinib as mesylate 400 mg - imatinib - imatinib-trima is indicated for the• treatment of adult patients and children 3 years of age and above with ph+ chronic myeloid leukaemia (ph+ -cml) in chronic phase, accelerated phase or blast crisis.• treatment of adult patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). • adjuvant treatment of adult patients following complete gross resection of kit (cd117) positive gist.• treatment of adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukemia (ph+ all) integrated with chemotherapy. • treatment of adult patients with relapsed or refractory ph+ all as monotherapy. • treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery.• treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with pdgfr (platelet-derived growth factor receptor) gene re-arrangements. • treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) who have the fip1l1-pdgfrα fusion kinase (mutational analysis or fish demonstration of chic2 allele deletion) and for patients with hes and/or cel who are fip1l1- pdgfrα fusion kinase negative. • treatment of adult patients with aggressive systemic mastocytosis (asm) without the d816v c-kit mutation.

Novi Zeland - engleski - Medsafe (Medicines Safety Authority)

aft pharmaceuticals ltd - imatinib mesilate 119.47mg equivalent to imatinib 100 mg;   - capsule - 100 mg - active: imatinib mesilate 119.47mg equivalent to imatinib 100 mg   excipient: crospovidone gelatin iron oxide red iron oxide yellow lactose monohydrate magnesium stearate titanium dioxide - treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive chronic myeloid leukaemia (ph+cml). treatment of adult and paediatic patients with ph+cml in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy.

Novi Zeland - engleski - Medsafe (Medicines Safety Authority)

aft pharmaceuticals ltd - imatinib mesilate 477.88mg equivalent to imatinib 400 mg;   - capsule - 400 mg - active: imatinib mesilate 477.88mg equivalent to imatinib 400 mg   excipient: crospovidone gelatin iron oxide black iron oxide red iron oxide yellow lactose monohydrate magnesium stearate titanium dioxide - treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive chronic myeloid leukaemia (ph+cml). treatment of adult and paediatic patients with ph+cml in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy.

Malta - engleski - Medicines Authority

fair-med healthcare gmbh planckstr. 13, 22765 hamburg, germany - imatinib - film-coated tablet - imatinib 100 mg - antineoplastic agents

Malta - engleski - Medicines Authority

fair-med healthcare gmbh planckstr. 13, 22765 hamburg, germany - imatinib - film-coated tablet - imatinib 400 mg - antineoplastic agents

Malta - engleski - Medicines Authority

teva pharma b.v. (utrecht) swensweg 5, 2031 ga haarlem, netherlands - imatinib - film-coated tablet - imatinib 100 mg - antineoplastic agents

Malta - engleski - Medicines Authority

teva pharma b.v. (utrecht) swensweg 5, 2031 ga haarlem, netherlands - imatinib - film-coated tablet - imatinib 400 mg - antineoplastic agents

Malta - engleski - Medicines Authority

cipla (eu) limited hillbrow house, hillbrow road, esher, surrey, kt10 9nw, united kingdom - imatinib mesilate - hard capsule - imatinib mesilate 100 mg - antineoplastic agents

Malta - engleski - Medicines Authority

cipla (eu) limited hillbrow house, hillbrow road, esher, surrey, kt10 9nw, united kingdom - imatinib mesilate - hard capsule - imatinib mesilate 400 mg - antineoplastic agents