Malta - Ingliż - Malta Medicines Authority

tad pharma gmbh heinz-lohmann-strasse 5, 27472 cuxhaven, germany - film-coated tablet - imatinib mesilate 400 mg - antineoplastic agents

New Zealand - Ingliż - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - imatinib mesilate 119.5mg equivalent to 100 mg imatinib base - capsule - 100 mg - active: imatinib mesilate 119.5mg equivalent to 100 mg imatinib base excipient: colloidal silicon dioxide crospovidone gelatin iron oxide red iron oxide yellow magnesium stearate microcrystalline cellulose tekprint red sw-1102 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 systemic mastocytosis (sm) without the d816v c-kit mutation or with c-kit mutational status unknown. · treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). · treatment of adult patients with kit+ (cd117) unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). · adjuvant treatment of adult patients following resection of kit+gist. · treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

New Zealand - Ingliż - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - imatinib mesilate 59.75mg equivalent to 50 mg imatinib base - capsule - 50 mg - active: imatinib mesilate 59.75mg equivalent to 50 mg imatinib base excipient: colloidal silicon dioxide crospovidone gelatin iron oxide yellow magnesium stearate microcrystalline cellulose 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 systemic mastocytosis (sm) without the d816v c-kit mutation or with c-kit mutational status unknown. · treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). · treatment of adult patients with kit+ (cd117) unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). · adjuvant treatment of adult patients following resection of kit+gist. · treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

New Zealand - Ingliż - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - imatinib mesilate 119.5mg equivalent to imatinib base 100 mg;   - film coated tablet - 100 mg - active: imatinib mesilate 119.5mg equivalent to imatinib base 100 mg   excipient: colloidal silicon dioxide crospovidone hypromellose magnesium stearate microcrystalline cellulose opadry red 00f15613 opadry yellow 00f12951 purified water - · 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 systemic mastocytosis (sm) without the d816v c-kit mutation or with c-kit mutational status unknown. · treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). · treatment of adult patients with kit+ (cd117) unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). · adjuvant treatment of adult patients following resection of kit+gist. · treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

New Zealand - Ingliż - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - imatinib mesilate 478mg equivalent to imatinib base 400 mg;   - film coated tablet - 400 mg - active: imatinib mesilate 478mg equivalent to imatinib base 400 mg   excipient: colloidal silicon dioxide crospovidone hypromellose magnesium stearate microcrystalline cellulose opadry red 00f15613 opadry yellow 00f12951 purified water - · 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 systemic mastocytosis (sm) without the d816v c-kit mutation or with c-kit mutational status unknown. · treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). · treatment of adult patients with kit+ (cd117) unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). · adjuvant treatment of adult patients following resection of kit+gist. · treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

Iżrael - Ingliż - Ministry of Health

novartis israel ltd - imatinib as mesylate - film coated tablets - imatinib as mesylate 100 mg - imatinib - imatinib - glivec 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. glivec is also indicated for the treatment of adult patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist).glivec 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.* adjuvant treatment of adult patients following complete gross resection of kit (cd117) positive gist.

Iżrael - Ingliż - Ministry of Health

novartis israel ltd - imatinib as mesylate - film coated tablets - imatinib as mesylate 400 mg - imatinib - imatinib - glivec 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. glivec is also indicated for the treatment of adult patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). glivec 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 for 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. * adjuvant treatment of adult patients following complete gross resection of kit (cd117) positive gist.

Iżrael - Ingliż - Ministry of Health

novartis israel ltd - imatinib as mesylate - film coated tablets - imatinib as mesylate 400 mg - imatinib - glivec 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. glivec is also indicated for the treatment of adult patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). glivec 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 for 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 . adjuvant treatment of adult patients following complete gross resection of kit (cd117) positive gist.

Malasja - Ingliż - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

camber laboratories sdn. bhd. - imatinib mesylate -

Malasja - Ingliż - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

camber laboratories sdn. bhd. - imatinib mesylate -