New Zealand - English - Medsafe (Medicines Safety Authority)

apotex nz ltd - imatinib mesilate 478mg equivalent to imatinib 400 mg - film coated tablet - 400 mg - active: imatinib mesilate 478mg equivalent to imatinib 400 mg excipient: colloidal silicon dioxide crospovidone hyprolose hypromellose iron oxide red iron oxide yellow macrogol 8000 magnesium stearate - 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.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

actavis uk ltd - imatinib mesilate - tablet - 400mg

New Zealand - English - Medsafe (Medicines Safety Authority)

devatis limited - imatinib mesilate 478mg equivalent to imatinib 400 mg;  ; imatinib mesilate 478mg equivalent to imatinib 400 mg - film coated tablet - 400 mg - active: imatinib mesilate 478mg equivalent to imatinib 400 mg   excipient: colloidal silicon dioxide crospovidone hypromellose opadry ii orange 85f230022 magnesium stearate microcrystalline cellulose active: imatinib mesilate 478mg equivalent to imatinib 400 mg excipient: colloidal silicon dioxide crospovidone hypromellose opadry ii orange 85f230022 magnesium stearate microcrystalline cellulose - treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive chronic myeloid leukaemia (ph+cml). treatment of adult and paediatric 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)

viatris limited - imatinib mesilate 478mg equivalent to imatinib free base 400 mg - film coated tablet - 400 mg - active: imatinib mesilate 478mg equivalent to imatinib free base 400 mg excipient: colloidal silicon dioxide crospovidone hypromellose magnesium stearate microcrystalline cellulose opadry beige 85f97378 - imatinib mylan is indicated for the: - treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive chronic myeloid leukaemia (ph+ cml) - treatment of adult and paediatric 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)

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).

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

cipla australia pty ltd - imatinib mesilate, quantity: 478 mg (equivalent: imatinib, qty 400 mg) - capsule - excipient ingredients: magnesium stearate; lactose; colloidal anhydrous silica; crospovidone; titanium dioxide; purified water; iron oxide yellow; iron oxide red; gelatin; sodium lauryl sulfate - imatinib gh is indicated for the: ? treatment of patients with chronic myeloid leukaemia (cml) ? treatment of adult 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).

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - imatinib mesilate 478mg equivalent to imatinib base 400 mg - film coated tablet - 400 mg - active: imatinib mesilate 478mg equivalent to imatinib base 400 mg excipient: colloidal silicon dioxide crospovidone hyprolose hypromellose iron oxide red iron oxide yellow macrogol 400 magnesium stearate microcrystalline cellulose povidone purified talc purified water - - treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive chronic myeloid leukaemia (ph+ cml) (for paediatric use see section dosage and administration). - treatment of adult and paediatric patients with ph+ cml in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy (for paediatric use see section dosage and administration).

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

teva pharma australia pty ltd - imatinib mesilate, quantity: 477.877 mg (equivalent: imatinib, qty 400 mg) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; crospovidone; magnesium stearate; purified water; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; macrogol 4000; polyvinyl alcohol - 1) imatinib-teva (imatinib) is indicated for the treatment of patients with chronic myeloid leukaemia (cml). 2) imatinib-teva (imatinib) is indicated for the treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. 3) imatinib-teva (imatinib) is indicated for the treatment of adult patients with relapsed or refractory ph+all as monotherapy. 4) imatinib-teva (imatinib) is indicated for the treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene rearrangements, where conventional therapies have failed. 5) imatinib-teva (imatinib) is indicated for the treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed. 6) imatinib-teva (imatinib) is indicated for the treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). 7) imatinib-teva (imatinib) is indicated for the treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) 8) imatinib-teva (imatinib) is indicated for the adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist. 9) imatinib-teva (imatinib) is indicated for the treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

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

teva pharma australia pty ltd - imatinib mesilate, quantity: 477.877 mg (equivalent: imatinib, qty 400 mg) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; crospovidone; magnesium stearate; purified water; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; macrogol 4000; polyvinyl alcohol - 1) imatinib-teva (imatinib) is indicated for the treatment of patients with chronic myeloid leukaemia (cml). 2) imatinib-teva (imatinib) is indicated for the treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. 3) imatinib-teva (imatinib) is indicated for the treatment of adult patients with relapsed or refractory ph+all as monotherapy. 4) imatinib-teva (imatinib) is indicated for the treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene rearrangements, where conventional therapies have failed. 5) imatinib-teva (imatinib) is indicated for the treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed. 6) imatinib-teva (imatinib) is indicated for the treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). 7) imatinib-teva (imatinib) is indicated for the treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) 8) imatinib-teva (imatinib) is indicated for the adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist. 9) imatinib-teva (imatinib) is indicated for the treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

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

teva pharma australia pty ltd - imatinib mesilate, quantity: 119.469 mg (equivalent: imatinib, qty 100 mg) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; crospovidone; magnesium stearate; purified water; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; macrogol 4000; polyvinyl alcohol - 1) imatinib-teva (imatinib) is indicated for the treatment of patients with chronic myeloid leukaemia (cml). 2) imatinib-teva (imatinib) is indicated for the treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. 3) imatinib-teva (imatinib) is indicated for the treatment of adult patients with relapsed or refractory ph+all as monotherapy. 4) imatinib-teva (imatinib) is indicated for the treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene rearrangements, where conventional therapies have failed. 5) imatinib-teva (imatinib) is indicated for the treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed. 6) imatinib-teva (imatinib) is indicated for the treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). 7) imatinib-teva (imatinib) is indicated for the treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) 8) imatinib-teva (imatinib) is indicated for the adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist. 9) imatinib-teva (imatinib) is indicated for the treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).