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

pharmacor pty ltd - imatinib mesilate, quantity: 478 mg (equivalent: imatinib, qty 400 mg) - tablet, film coated - excipient ingredients: magnesium stearate; titanium dioxide; macrogol 8000; hypromellose; purified talc - gilmat 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 hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) ?treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) ?adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist (see dosage and administration and clinical trials) ? treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

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

pharmacor pty ltd - imatinib mesilate, quantity: 478 mg (equivalent: imatinib, qty 400 mg) - tablet, film coated - excipient ingredients: magnesium stearate; titanium dioxide; macrogol 8000; hypromellose; purified talc - gilmat 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 hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) ?treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) ?adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist (see dosage and administration and clinical trials) ? treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

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

pharmacor pty ltd - imatinib mesilate, quantity: 119.5 mg (equivalent: imatinib, qty 100 mg) - tablet, film coated - excipient ingredients: magnesium stearate; titanium dioxide; macrogol 8000; hypromellose; purified talc - gilmat 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 hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) ?treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) ?adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist (see dosage and administration and clinical trials) ? treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - imatinib mesilate 119.5mg equivalent to imatinib free base 100 mg - film coated tablet - 100 mg - active: imatinib mesilate 119.5mg equivalent to imatinib free base 100 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)

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.

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

sandoz pty ltd - imatinib, quantity: 400 mg (equivalent: imatinib mesilate, qty 478 mg) - tablet, film coated - excipient ingredients: colloidal anhydrous silica; crospovidone; microcrystalline cellulose; hypromellose; magnesium stearate; purified talc; iron oxide red; macrogol 4000; iron oxide yellow - imatinib sandoz 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). -treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp)

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

sandoz pty ltd - imatinib, quantity: 100 mg (equivalent: imatinib mesilate, qty 1195 mg) - tablet, film coated - excipient ingredients: magnesium stearate; colloidal anhydrous silica; microcrystalline cellulose; crospovidone; hypromellose; purified talc; iron oxide yellow; macrogol 4000; iron oxide red - imatinib sandoz 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). -treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp)

European Union - English - EMA (European Medicines Agency)

teva b.v. - imatinib mesilate - dermatofibrosarcoma; gastrointestinal stromal tumors; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastic agents - imatinib teva b.v. is indicated for the treatment of: , 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., paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis., adult patients with ph+ cml in 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 teva b.v. is indicated for: , the 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. patients who have a low or very low risk of recurrence should not receive adjuvant treatment., 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. there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.,

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

cipla australia pty ltd - imatinib mesilate, quantity: 59.75 mg (equivalent: imatinib, qty 50 mg) - capsule - excipient ingredients: lactose; crospovidone; colloidal anhydrous silica; magnesium stearate; titanium dioxide; purified water; gelatin - imatinib capsules indicated for: - 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/myeloproflierative 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)

cipla australia pty ltd - imatinib mesilate, quantity: 59.75 mg (equivalent: imatinib, qty 50 mg) - capsule - excipient ingredients: lactose; crospovidone; colloidal anhydrous silica; magnesium stearate; titanium dioxide; purified water; gelatin - imatinib capsules indicated for: - 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/myeloproflierative 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)