Euroopa Liit - inglise - EMA (European Medicines Agency)

medac - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; leukemia, myelogenous, chronic, bcr-abl positive; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome - protein kinase inhibitors - imatinib medac 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;adult and paediatric 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;adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery.the 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. except in newly diagnosed chronic phase cml, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.

Euroopa Liit - inglise - EMA (European Medicines Agency)

teva b.v. - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - antineoplastic agents, protein kinase inhibitors - imatinib teva is indicated for the treatment ofadult 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.the effect of imatinib on the outcome of bone marrow transplantation has not been determined.imatinib teva is indicated forthe 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 (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. 

Uus-Meremaa - inglise - Medsafe (Medicines Safety Authority)

devatis limited - imatinib mesilate 478mg equivalent to imatinib 400 mg;  ; imatinib mesilate 478mg equivalent to imatinib 400 mg - film coated tablet - 400 mg - active: imatinib mesilate 478mg equivalent to imatinib 400 mg   excipient: colloidal silicon dioxide crospovidone hypromellose opadry ii orange 85f230022 magnesium stearate microcrystalline cellulose active: imatinib mesilate 478mg equivalent to imatinib 400 mg excipient: colloidal silicon dioxide crospovidone hypromellose opadry ii orange 85f230022 magnesium stearate microcrystalline cellulose - 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.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - imatinib mesilate -

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - imatinib mesilate -

Austraalia - inglise - 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).

Suurbritannia - inglise - MHRA (Medicines & Healthcare Products Regulatory Agency)

actavis uk ltd - imatinib mesilate - tablet - 100mg

Suurbritannia - inglise - MHRA (Medicines & Healthcare Products Regulatory Agency)

actavis uk ltd - imatinib mesilate - tablet - 400mg

Austraalia - inglise - 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)

Austraalia - inglise - 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)