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).

Israel - English - Ministry of Health

teva israel ltd - imatinib as mesylate - film coated tablets - imatinib as mesylate 100 mg - imatinib - 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.imatinib teva is also indicated for the treament of :adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukemia (ph+all) integrated with chemotherapy.adult patients with relapsed or refractory ph + all as monotherapy.adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery.adult patients with myelodyspiastic/myeloproliferative diseases (mds/mpd) associated with pdgfr ( platelet - derived growth factor receptor ) gene re- arrangements.adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) who have the fip1l1- pdgfralfa fusion kinase (mutational analysis or fish demonstration fo chic2 allele deletion) and for patients with hes and/or cel who are fip1l1-pdgfr alfa fusion kinase negative .adult patients with aggressive systemic mastocytosis (asm) without the d816v c-kit mutation.imatinib teva is also indicated for the treatment of adult patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist)imatinib teva is also indicated for adjuvant treatment of adult patients following complete gross resection of kit (cd117) positive gist.

Israel - English - Ministry of Health

teva israel ltd - imatinib as mesylate - film coated tablets - imatinib as mesylate 400 mg - imatinib - 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.imatinib teva is also indicated for the treament of :adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukemia (ph+all) integrated with chemotherapy.adult patients with relapsed or refractory ph + all as monotherapy.adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery.adult patients with myelodyspiastic/myeloproliferative diseases (mds/mpd) associated with pdgfr ( platelet - derived growth factor receptor ) gene re- arrangements.adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) who have the fip1l1- pdgfralfa fusion kinase (mutational analysis or fish demonstration fo chic2 allele deletion) and for patients with hes and/or cel who are fip1l1-pdgfr alfa fusion kinase negative .adult patients with aggressive systemic mastocytosis (asm) without the d816v c-kit mutation.imatinib teva is also indicated for the treatment of adult patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist)imatinib teva is also indicated for adjuvant treatment of adult patients following complete gross resection of kit (cd117) positive gist.

Israel - English - Ministry of Health

taro international ltd, israel - imatinib as mesylate - film coated tablets - imatinib as mesylate 100 mg - imatinib - imatinib taro 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

taro international ltd, israel - imatinib as mesylate - film coated tablets - imatinib as mesylate 400 mg - imatinib - imatinib taro 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.

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)

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)

Malta - English - Medicines Authority

aspen healthcare malta limited 89, level 0 triq is-siggiewi siggiewi, sgw 2021, , malta - imatinib mesilate - hard capsule - imatinib mesilate 100 mg - antineoplastic agents