United States - English - NLM (National Library of Medicine)

golden state medical supply, inc. - imatinib mesylate (unii: 8a1o1m485b) (imatinib - unii:bkj8m8g5hi) - imatinib 100 mg - newly diagnosed adult and pediatric patients with philadelphia chromosome positive chronic myeloid leukemia (ph+ cml) in chronic phase. patients with philadelphia chromosome positive chronic myeloid leukemia in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. adult patients with relapsed or refractory philadelphia chromosome positive acute lymphoblastic leukemia (ph+ all). adult patients with myelodysplastic/myeloproliferative diseases associated with pdgfr (platelet-derived growth factor receptor) gene re-arrangements as determined with an fda-approved test [ see dosage and administration ( 2.6) ]. adult patients with aggressive systemic mastocytosis without the d816v c-kit mutation as determined with an fda-approved test [ see dosage and administration ( 2.7) ] or with c-kit mutational status unknown. adult patients with hypereosinophilic syndrome and/or chronic eosinoph

United States - English - NLM (National Library of Medicine)

northstar rxllc - imatinib mesylate (unii: 8a1o1m485b) (imatinib - unii:bkj8m8g5hi) - imatinib 100 mg - newly diagnosed adult and pediatric patients with philadelphia chromosome positive chronic myeloid leukemia (ph+ cml) in chronic phase. patients with philadelphia chromosome positive chronic myeloid leukemia in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. adult patients with relapsed or refractory philadelphia chromosome positive acute lymphoblastic leukemia (ph+ all). pediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukemia (ph+ all) in combination with chemotherapy. adult patients with myelodysplastic/myeloproliferative diseases associated with platelet-derived growth factor receptor ( pdgfr) gene re-arrangements. adult patients with aggressive systemic mastocytosis without the d816v c-kit mutation or with c-kit mutational status unknown. adult patients with hypereosinophilic syndrome and/or chronic eosinophilic leukemia who have the fip1l1­-pdgfrα fusion kinase (mutational analysis or fluorescence in situ hybrid

Israel - English - 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.

Israel - English - 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.

New Zealand - English - 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.

New Zealand - English - 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 - English - Medicines Authority

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

Malta - English - Medicines Authority

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

Malta - English - Medicines Authority

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

Malta - English - Medicines Authority

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