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

dr reddys laboratories australia pty ltd - imatinib mesilate, quantity: 119.47 mg (equivalent: imatinib, qty 100 mg) - capsule, hard - excipient ingredients: purified water; gelatin; crospovidone; titanium dioxide; iron oxide yellow; sodium lauryl sulfate; sodium stearylfumarate; iron oxide red; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; ethanol absolute; ammonia - 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). ? 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)

Canada - English - Health Canada

pharmascience inc - imatinib (imatinib mesylate) - tablet - 100mg - imatinib (imatinib mesylate) 100mg - antineoplastic agents

Canada - English - Health Canada

pharmascience inc - imatinib (imatinib mesylate) - tablet - 400mg - imatinib (imatinib mesylate) 400mg - antineoplastic agents

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.

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: 119.5 mg (equivalent: imatinib, qty 100 mg) - capsule - excipient ingredients: colloidal anhydrous silica; lactose; magnesium stearate; crospovidone; titanium dioxide; purified water; iron oxide yellow; iron oxide red; gelatin; sodium lauryl sulfate - ? 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).

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 - ? 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).

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinib - imatinib accord is indicated for the treatment of- adult and 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.- adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or 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.- adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery.- 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 treatmentthe effect of imatinib on the outcome of bone marrow transplantation has not been determined.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 dfsp. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5.1). except in newly diagnosed chronic phase cml, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.