Malta - English - Medicines Authority

cipla (eu) limited hillbrow house, hillbrow road, esher, surrey, kt10 9nw, united kingdom - imatinib mesilate - hard capsule - imatinib mesilate 400 mg - antineoplastic agents

Ireland - English - HPRA (Health Products Regulatory Authority)

cipla (eu) limited - imatinib mesilate - capsules hard - 400 milligram - other cytostatics - antineoplastic agents; protein kinase inhibitor - it 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-pdgfr
rearrangement

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).

Malta - English - Medicines Authority

cipla (eu) limited hillbrow house, hillbrow road, esher, surrey, kt10 9nw, united kingdom - imatinib mesilate - hard capsule - imatinib mesilate 100 mg - antineoplastic agents

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).

Kenya - English - Pharmacy and Poisons Board

cipla limited cipla house, peninsula business park, ganpatrao - imatinib mesylate - capsule, hard - each hard gelatin capsules contains: imatinib… - imatinib

Ireland - English - HPRA (Health Products Regulatory Authority)

cipla (eu) limited - imatinib mesilate - capsules hard - 100 milligram - other cytostatics - antineoplastic agents; protein kinase inhibitor - it s 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-pdgfr
rearrangement

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 - 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).

Kenya - English - Pharmacy and Poisons Board

cipla limited cipla house, peninsula business park, ganpatrao - imatinib mesylate - capsule, hard - imatinib mesylate ph. eur equivalent to imatinib… - imatinib

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).