Malta - English - Medicines Authority

bioorganics bv microweg 22, 6545cm nijmegen, netherlands - imatinib - film-coated tablet - imatinib 400 mg - antineoplastic agents

New Zealand - English - Medsafe (Medicines Safety Authority)

rex medical ltd - imatinib mesilate 119.5mg equivalent to imatinib 100 mg - capsule - 100 mg - active: imatinib mesilate 119.5mg equivalent to imatinib 100 mg excipient: colloidal silicon dioxide crospovidone gelatin iron oxide red iron oxide yellow lactose magnesium stearate purified water 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. - treatment of adult patients with new diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+all) integrated with chemotherapy. - treatment of adult patients with relapsed or refractory ph+all as monotherapy. - treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. - treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). - treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

New Zealand - English - Medsafe (Medicines Safety Authority)

rex medical ltd - imatinib mesilate 478mg equivalent to imatinib 400 mg - capsule - 400 mg - active: imatinib mesilate 478mg equivalent to imatinib 400 mg excipient: colloidal silicon dioxide crospovidone gelatin iron oxide red   iron oxide yellow   lactose magnesium stearate purified water 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. - treatment of adult patients with new diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+all) integrated with chemotherapy. - treatment of adult patients with relapsed or refractory ph+all as monotherapy. - treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. - treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). - treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

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

golden state medical supply, inc. - imatinib mesylate (unii: 8a1o1m485b) (imatinib - unii:bkj8m8g5hi) - 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 hybridiz

Australia - English - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - imatinib mesilate, quantity: 119.47 mg (equivalent: imatinib, qty 100 mg) - tablet, film coated - excipient ingredients: sodium stearylfumarate; hypromellose; purified talc; iron oxide yellow; iron oxide red - the proposed imatinib tablet is indicated for the:,? treatment of patients with chronic myeloid leukaemia (cml),? treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy,? treatment of adult patients with relapsed or refractory ph+ all as monotherapy,? treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements, where conventional therapies have failed,? treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed,? treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel),? adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

Australia - English - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - imatinib mesilate, quantity: 716.82 mg (equivalent: imatinib, qty 600 mg) - tablet, film coated - excipient ingredients: sodium stearylfumarate; hypromellose; purified talc; iron oxide yellow; iron oxide red - the proposed imatinib tablet is indicated for the:,? treatment of patients with chronic myeloid leukaemia (cml),? treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy,? treatment of adult patients with relapsed or refractory ph+ all as monotherapy,? treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements, where conventional therapies have failed,? treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed,? treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel),? adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

Australia - English - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - imatinib mesilate, quantity: 716.82 mg (equivalent: imatinib, qty 600 mg) - tablet, film coated - excipient ingredients: sodium stearylfumarate; hypromellose; purified talc; iron oxide yellow; iron oxide red - the proposed imatinib tablet is indicated for the:,? treatment of patients with chronic myeloid leukaemia (cml),? treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy,? treatment of adult patients with relapsed or refractory ph+ all as monotherapy,? treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements, where conventional therapies have failed,? treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed,? treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel),? adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

Australia - English - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - imatinib mesilate, quantity: 477.88 mg (equivalent: imatinib, qty 400 mg) - tablet, film coated - excipient ingredients: sodium stearylfumarate; hypromellose; purified talc; iron oxide yellow; iron oxide red - the proposed imatinib tablet is indicated for the:,? treatment of patients with chronic myeloid leukaemia (cml),? treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy,? treatment of adult patients with relapsed or refractory ph+ all as monotherapy,? treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements, where conventional therapies have failed,? treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed,? treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel),? adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

Australia - English - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - imatinib mesilate, quantity: 119.47 mg (equivalent: imatinib, qty 100 mg) - tablet, film coated - excipient ingredients: sodium stearylfumarate; hypromellose; purified talc; iron oxide yellow; iron oxide red - the proposed imatinib tablet is indicated for the:,? treatment of patients with chronic myeloid leukaemia (cml),? treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy,? treatment of adult patients with relapsed or refractory ph+ all as monotherapy,? treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements, where conventional therapies have failed,? treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed,? treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel),? adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

Australia - English - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - imatinib mesilate, quantity: 477.88 mg (equivalent: imatinib, qty 400 mg) - tablet, film coated - excipient ingredients: sodium stearylfumarate; hypromellose; purified talc; iron oxide yellow; iron oxide red - the proposed imatinib tablet is indicated for the:,? treatment of patients with chronic myeloid leukaemia (cml),? treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy,? treatment of adult patients with relapsed or refractory ph+ all as monotherapy,? treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements, where conventional therapies have failed,? treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed,? treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel),? adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).