Ireland - English - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - imatinib mesilate - film-coated tablet - 400 milligram(s) - protein kinase inhibitors; imatinib

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) imatiqual (imatinib) is indicated for the treatment of patients with chronic myeloid leukaemia (cml). 2) imatiqual (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) imatiqual (imatinib) is indicated for the treatment of adult patients with relapsed or refractory ph+all as monotherapy. 4) imatiqual (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) imatiqual (imatinib) is indicated for the treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed. 6) imatiqual (imatinib) is indicated for the treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). 7) imatiqual (imatinib) is indicated for the treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) 8) imatiqual (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) imatiqual (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) glibine (imatinib) is indicated for the treatment of patients with chronic myeloid leukaemia (cml). 2) glibine (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) glibine (imatinib) is indicated for the treatment of adult patients with relapsed or refractory ph+all as monotherapy. 4) glibine (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) glibine (imatinib) is indicated for the treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed. 6) glibine (imatinib) is indicated for the treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). 7) glibine (imatinib) is indicated for the treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) 8) glibine (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) glibine (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) imatiqual (imatinib) is indicated for the treatment of patients with chronic myeloid leukaemia (cml). 2) imatiqual (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) imatiqual (imatinib) is indicated for the treatment of adult patients with relapsed or refractory ph+all as monotherapy. 4) imatiqual (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) imatiqual (imatinib) is indicated for the treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed. 6) imatiqual (imatinib) is indicated for the treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). 7) imatiqual (imatinib) is indicated for the treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) 8) imatiqual (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) imatiqual (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) glibine (imatinib) is indicated for the treatment of patients with chronic myeloid leukaemia (cml). 2) glibine (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) glibine (imatinib) is indicated for the treatment of adult patients with relapsed or refractory ph+all as monotherapy. 4) glibine (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) glibine (imatinib) is indicated for the treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed. 6) glibine (imatinib) is indicated for the treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). 7) glibine (imatinib) is indicated for the treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) 8) glibine (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) glibine (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) imatiqual (imatinib) is indicated for the treatment of patients with chronic myeloid leukaemia (cml). 2) imatiqual (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) imatiqual (imatinib) is indicated for the treatment of adult patients with relapsed or refractory ph+all as monotherapy. 4) imatiqual (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) imatiqual (imatinib) is indicated for the treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed. 6) imatiqual (imatinib) is indicated for the treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). 7) imatiqual (imatinib) is indicated for the treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) 8) imatiqual (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) imatiqual (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) glibine (imatinib) is indicated for the treatment of patients with chronic myeloid leukaemia (cml). 2) glibine (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) glibine (imatinib) is indicated for the treatment of adult patients with relapsed or refractory ph+all as monotherapy. 4) glibine (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) glibine (imatinib) is indicated for the treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed. 6) glibine (imatinib) is indicated for the treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). 7) glibine (imatinib) is indicated for the treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) 8) glibine (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) glibine (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) imatiqual (imatinib) is indicated for the treatment of patients with chronic myeloid leukaemia (cml). 2) imatiqual (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) imatiqual (imatinib) is indicated for the treatment of adult patients with relapsed or refractory ph+all as monotherapy. 4) imatiqual (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) imatiqual (imatinib) is indicated for the treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed. 6) imatiqual (imatinib) is indicated for the treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). 7) imatiqual (imatinib) is indicated for the treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) 8) imatiqual (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) imatiqual (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) glibine (imatinib) is indicated for the treatment of patients with chronic myeloid leukaemia (cml). 2) glibine (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) glibine (imatinib) is indicated for the treatment of adult patients with relapsed or refractory ph+all as monotherapy. 4) glibine (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) glibine (imatinib) is indicated for the treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed. 6) glibine (imatinib) is indicated for the treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). 7) glibine (imatinib) is indicated for the treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) 8) glibine (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) glibine (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)

sun pharma anz pty ltd - imatinib mesilate, quantity: 478 mg - tablet, film coated - excipient ingredients: magnesium stearate; hypromellose; purified talc; iron oxide yellow; macrogol 6000; iron oxide red - imatinib rbx 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 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).